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HOME > Clin Endosc > Volume 58(6); 2025 > Article
Original Article Efficacy of double half-pigtail plastic stents for endoscopic biliary drainage of acute calculous cholangitis
Toshitaka Sakai1orcid, Yoshihide Kanno1orcid, Shinsuke Koshita1orcid, Takahisa Ogawa1orcid, Hiroaki Kusunose1orcid, Keisuke Yonamine1orcid, Kazuaki Miyamoto1orcid, Fumisato Kozakai1orcid, Haruka Okano1orcid, Kento Hosokawa1orcid, Hidehito Sumiya1orcid, Jun Horaguchi2orcid, Masaya Oikawa3orcid, Takashi Tsuchiya3orcid, Yutaka Noda1orcid, Kei Ito1orcid
Clinical Endoscopy 2025;58(6):898-908.
DOI: https://doi.org/10.5946/ce.2025.134
Published online: November 11, 2025

1Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan

2Natori Chuo Clinic, Natori, Japan

3Department of Surgery, Sendai City Medical Center, Sendai, Japan

Correspondence: Toshitaka Sakai Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Miyagi, Japan E-mail: t.sakai@openhp.or.jp
• Received: April 24, 2025   • Revised: July 22, 2025   • Accepted: August 12, 2025

© 2025 Korean Society of Gastrointestinal Endoscopy

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • Background/Aims:
    Plastic stent placement is required when biliary stones cannot be completely removed during the initial endoscopic retrograde cholangiopancreatography (ERCP). Although double half-pigtail plastic stents (DHPs) help prevent stent migration, their clinical utility has not yet been evaluated.
  • Methods:
    We retrospectively reviewed data from 221 patients who underwent DHP placement for acute calculous cholangitis (ACC) between January 2015 and March 2024. Patient without complete stone removal during initial ERCP were included. Clinical success, adverse events, recurrent biliary obstruction (RBO), and time to RBO (TRBO) were compared in 21 patients treated with straight plastic stents (STs) under similar conditions.
  • Results:
    Clinical success was achieved in 99% of patients in the DHP group and 95% of the ST group (p=0.13). Adverse event rates were comparable between groups. During follow-up, the DHP group had significantly lower stent occlusion (2% vs. 20%, p<0.01) and migration rates (4% vs. 15%, p=0.02), leading to a lower RBO rate (5% vs. 35%, p<0.01). The median TRBO was significantly longer in the DHP group (585 vs. 247 days, p<0.01).
  • Conclusions:
    DHPs had comparable efficacy to STs, with significantly fewer stent-related adverse events. This may be a potential option for biliary drainage in ACC.
  • Keywords: Acute calculous cholangitis; Choledocholithiasis; Double half-pigtail plastic stent; Endoscopic retrograde cholangiopancreatography; Recurrent biliary obstruction
Acute calculous cholangitis (ACC) is a potentially fatal disease caused by biliary stasis and bacterial infection following biliary obstruction. Therefore, urgent intervention is required. According to current guidelines,1-3 endoscopic stone removal or biliary drainage is recommended as the first-line intervention for ACC.
Endoscopic stone removal is performed using a basket-and-balloon catheter after endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation. In recent years, for large biliary stones, endoscopic papillary large balloon dilation (EPLBD) and peroral cholangioscopy (POCS)-assisted electrohydraulic lithotripsy (EHL) have been used, with numerous reports demonstrating high rates of complete stone removal during the initial session.4-7 However, complete stone removal is occasionally difficult for several reasons, such as severe comorbidities and large stones requiring temporary or permanent biliary drainage using plastic stents.
For effective drainage, the distal (hepatic) end of the plastic stent must be inserted distal to the stones. Additionally, procedural risks should be minimized by quick and safe placement. An ideal stent should effectively resolve infection while maintaining stable bile flow. However, only a few studies have evaluated the optimal stent type for ACC.
Straight plastic stents (STs) have traditionally been used for biliary drainage in ACC as most STs feature a preloaded system with a threaded connection to ensure procedural safety. However, STs are prone to slippage resulting in migration, and may have functional limitations due to the small number of side holes. To address these issues, double half-pigtail plastic stents (DHPs) with a preloaded system and anti-migration design (Through & Pass Double Pit; GADELIUS MEDICAL K.K.) were developed (Fig. 1). These stents are also equipped with multiple side holes to reduce the risk of dysfunction. Unlike the conventional fully curved pigtail design, the semicircular curvature of DHPs is expected to reduce the risk of stent implantation into the liver parenchyma. DHPs became commercially available in 2015 and have been used at our center since its launch. However, no studies to date have evaluated the clinical outcomes of DHPs for biliary drainage in patients with ACC. Therefore, we conducted a comparative evaluation of DHPs and STs for the treatment of ACC.
Patients
Patients who underwent plastic stent placement for ACC during initial endoscopic retrograde cholangiopancreatography (ERCP) without complete stone removal were included in this study. Patients were excluded if they had intrahepatic stones, biliary malignancy or strictures, a history of previous ERCP, multiple plastic stents, or had previously undergone surgical choledochojejunostomy.
Treatment strategy for ACC
According to the Tokyo Guidelines 2018,8 ACC is defined as cases with elevated inflammatory markers and hepatobiliary enzymes in blood tests, along with imaging evidence of bile duct dilation or bile duct stones (computed tomography scans, magnetic resonance images, and/or endoscopic ultrasonography). Since August 2017, prophylactic diclofenac suppositories have been routinely administered before the procedure to all patients without contraindications.9,10
For ERCP, a duodenoscope (TJF-260V or TJF-290V; Olympus Co.) or balloon-assisted enteroscope (SIF-Q260 or SIF-H290S; Olympus Co.) was used. After biliary cannulation, cholangiography was performed to assess the bile duct diameter, strictures, distal bile duct angulation, and size and number of stones. After placing a 0.025-inch guidewire in the duct, EST was performed with at least a middle incision. If both stone size and common bile duct (CBD) diameter were 10 mm or larger, EPLBD was considered. Stone removal was performed using a basket-and-balloon catheter. The stones were fragmented before removal using mechanical lithotripsy (ML) or POCS-assisted EHL, if necessary. Factors such as large stones, multiple stones, severe cholangitis, anticoagulant therapy, post-EST bleeding, and respiratory or circulatory dysfunction are considered challenges to complete stone removal. When stones could not be completely removed during the initial session because of these factors, a DHP (7–8.5 Fr, 8–10 cm) or ST (Flexima, Boston Scientific Japan; or Through & Pass, GADELIUS MEDICAL K.K. 7–10 Fr, 5–10 cm) was placed. The surgeon determined the type of plastic stent to be placed. DHPs were selected when the guidewire could be advanced into the intrahepatic bile duct with a mild curvature suitable for DHP placement. In cases where guidewire insertion into an appropriately shaped intrahepatic duct was unsuccessful or when the clinical condition precluded prolonged guidewire manipulation, STs were used instead. In most patients, bile duct stones were removed after their general condition improved. If repeat ERCP was deemed difficult or unfavorable due to advanced age, poor performance status, or patient preference, the stones were left untreated while the stent was maintained.
Outcome measurements
We retrospectively investigated the following outcomes using clinical databases and the medical records from our center: (1) clinical success rates of endoscopic interventions, (2) adverse events related to endoscopic procedures, and (3) long-term outcomes during surveillance after successful endoscopic interventions.
Definitions
Distal CBD angulation on cholangiography was defined as the first angulation from the ampullary orifice along the course of the CBD.11 According to the Tokyo criteria 2024,12 clinical success was defined as cases in which serum levels of total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) were normalized or decreased to less than half of their peak levels and inflammation was resolved within 14 days after the procedure. Stent occlusion was defined as an elevation in hepatobiliary enzymes compared to baseline after clinical success without evidence of stent dislocation in imaging studies or endoscopic findings. Stent migration was defined as complete or partial stent dislodgement, with the hepatic end located downstream of the most hepatic stone or the duodenal-side end positioned upstream of the papilla, as observed during imaging studies or endoscopic findings in cases of clinical success, regardless of the recurrence of biliary obstruction. Recurrent biliary obstruction (RBO) is defined as stent occlusion or migration, resulting in biliary obstruction or biliary intervention, including stent exchange or stone removal. Time to RBO (TRBO) was defined as the period from stent placement to reintervention for RBO, including stent exchange or stone removal. Adverse events related to the endoscopic procedures were evaluated according to the Tokyo criteria 2024.12
Statistical analysis
Pearson’s χ2 test or Fisher’s exact test was used for categorical variables. Student's t-test or the Mann-Whitney U-test was used for continuous variables. Time-to-event data were evaluated using Kaplan–Meier survival curves and compared using the log-rank test. To identify potential risk factors for RBO following successful endoscopic intervention, variables with a p-value <0.2 in univariate analysis were entered into a multivariate Cox proportional hazards model. Statistical significance was set at p<0.05.
Statcel3 (OMS Publication), SPSS software (ver. 24.0; IBM Japan, Ltd.), and EZR (Jichi Medical University),13 a graphical user interface for R (The R Foundation for Statistical Computing), were used for analyses.
Ethical statements
This study was approved by the Ethics Committee of Sendai City Medical Center (registration number: 2024-0055).
Baseline patient characteristics
Among the 3,194 patients who underwent ERCP for ACC between January 2015 and March 2024, 221 were treated with a single DHP (DHP group) and 21 were treated with a single ST (ST group).
The baseline characteristics of 242 patients are presented in Table 1. There were no significant differences between the two groups in terms of age, sex, performance status, surgically altered anatomy, severity of cholangitis, or antithrombotic therapy. The white blood cell (WBC) count was significantly higher in the DHP group (9,150/mL vs. 5,950/mL, p=0.03), whereas ALT level was considerably higher in the ST group (142 IU/L vs. 170 IU/L, p=0.02).
Endoscopic procedures for ACC
Details of the initial endoscopic intervention and the reasons for ST placement are shown in Table 2. No significant intergroup differences were observed in the number of CBD stones, maximum stone diameter, maximum CBD diameter, or distal CBD angulation. During the initial intervention, POCS-assisted EHL (0.9% vs. 9.5%, p<0.01) and pancreatic duct stent placement (9.0% vs. 23.8%, p=0.03) were more frequently performed in the ST group. Regarding the reasons for incomplete stone removal, difficulty in stone removal was the most common in both groups, followed by ongoing antithrombotic therapy preventing EST and poor general condition due to severe cholangitis, without significant differences. Stents with a diameter of 8.5 Fr or larger were more commonly used in the ST group with a statistical significance (2.3% vs. 14.3%, p<0.01).
Clinical success rate and adverse events of endoscopic procedures for ACC
The clinical success rates were 99.1% and 95.2% in the DHP and ST groups, respectively (p=0.13) (Table 3). Regarding adverse events, post-ERCP pancreatitis and post-EST bleeding were observed, although there were no significant differences in the occurrence rate or severity between the groups. All the patients improved with conservative and/or endoscopic treatments. No gastrointestinal perforations, duodenal ulcerations, or procedure-related deaths were observed.
Clinical courses after successful endoscopic procedures
After successful plastic-stent placement, 90% and 95% of the patients in the DHP and ST groups, respectively, underwent a second ERCP, resulting in complete stone removal in all cases (p=0.47). In the remaining patients, the plastic stent was maintained without stone removal. During the mean follow-up period of 818 days after plastic stent placement, stent occlusion was observed in 2% and 20% of in the DHP and ST groups, respectively (p<0.01), and stent migration occurred in 4% and 15% of cases, respectively (p=0.02). The RBO rates were 5% and 35%, respectively (p<0.01), indicating significantly fewer adverse events related to DHPs. Additionally, the median TRBO duration was considerably longer in the DHP group (585 vs. 247 days, p<0.01). Likewise, stent dysfunction within 30 and 90 days was less frequent in the DHP group with statistical significance (2% vs. 25% and 3% vs. 25%, respectively; p<0.01) (Fig. 2). To clarify the risk factors associated with the development of RBO following successful endoscopic intervention, 25 potential variables were subjected to univariate and multivariate analyses. Four variables (p<0.2) in the univariate analysis using the log-rank test were included in the multivariate model: use of DHPs (p<0.01), anticoagulant therapy (p=0.13), maximum stone diameter ≥15 mm (p=0.11), and incomplete stone removal due to technical difficulty (p=0.12). Multivariate analysis using the Cox proportional hazards model identified the use of DHPs as a significant factor associated with a lower risk of RBO (p<0.01; hazard ratio, 0.25; 95% confidence interval, 0.09–0.71) (Table 4).
Propensity score matching and analysis
Propensity score matching was performed to minimize confounding factors owing to baseline differences. Propensity scores were estimated using logistic regression based on the following covariates: age, sex, performance status, surgically altered anatomy, severity of cholangitis, use of antithrombotic therapy, and laboratory parameters on admission (WBC, C-reactive protein [CRP], AST, ALT, and total bilirubin). One-to-one nearest-neighbor matching without replacement was performed using a caliper width of 0.2.
Baseline characteristics and initial endoscopic interventions after propensity score matching are shown in Table 5. There were no significant differences between the two groups in terms of age, sex, performance status, surgically altered anatomy, severity of cholangitis, use of antithrombotic therapy, or laboratory parameters on admission (WBC, CRP, AST, ALT, and total bilirubin). The results of the initial endoscopic interventions, including stone and CBD characteristics, plastic stent diameter, POCS-assisted EHL, and pancreatic duct stent placement, were also not significantly different between the two groups. The median TRBO was considerably longer in the DHP group (not reached vs. 247 days, p=0.04) (Fig. 3).
Subgroup analysis: indefinite stent maintenance
After successful plastic stent placement, 21 patients in the DHP group and one patient in the ST group underwent indefinite stent maintenance. In the indefinite stent maintenance group, there was no significant difference in the rate of DHP versus ST use (p=0.50).
Patients in the indefinite stent maintenance group were significantly older (p<0.01) and more frequently had a surgically altered anatomy (p<0.01) than those in the stone removal group. Additionally, this group exhibited a significantly greater number of bile duct stones (p=0.02), a larger maximum CBD diameter (p<0.01), and a higher prevalence of steep distal CBD angulation (p<0.01). The median TRBO in the indefinite stent maintenance group was 635 days (Table 6).
In this study, we demonstrated the utility of DHPs for endoscopic biliary drainage in ACC. Although many studies have been conducted on endoscopic drainage and discussed the stents of choice for malignant biliary strictures,14-18 the focus has primarily been on stone removal techniques.4,7,19–21 Few studies have explored the initial drainage, stent selection, and subsequent management.22,23 DHPs were comparable to STs, with effective clinical success in nearly all patients and significantly fewer RBOs, even after propensity score matching. This difference may be associated with the DHP design. Its shape allows it to fit into the intrahepatic bile ducts, preventing migration. Indeed, the short- and long-term migration rates were lower in the DHP compared to the ST group. Additionally, multiple side holes could enhance the drainage capability and prolong the functional period, considering the less frequent occlusion of DHPs despite the frequent use of 8.5-Fr or larger stents. In a recent retrospective study, Paspatis et al.24 compared straight and double-pigtail plastic stents in patients with irretrievable bile duct stones and reported significantly higher rates of distal stent migration in the double-pigtail group (8.4% vs. 14.6% at 6 months, 21.4% vs. 27.7% at 12 months, 27% vs. 43.5% at 18 months, and 37.2% vs. 60.4% at 24 months, respectively, p=0.004, log-rank test). However, comparisons between our findings and those of Paspatis et al.24 must be made cautiously due to substantial heterogeneity.
First, the type of stent used differed between studies. Paspatis et al.24 compared straight and double-pigtail stents, and our study focused on STs and DHPs. Although their report lacked detailed procedural descriptions, the average stent length of 7 cm suggested that the double-pigtail stents were deployed within the extrahepatic bile duct. In contrast, our DHP stents were placed in the intrahepatic bile ducts, and their fit within the ductal anatomy may have contributed to lower distal stent migration rates. Additionally, Paspatis et al.24 used larger-caliber straight stents (mean, 10.4 Fr) than those used in our study (mean, 7.3 Fr).
Second, there were differences in patient characteristics and biliary drainage indications. Paspatis et al.24 included patients with irretrievable bile duct stones regardless of the presence of cholangitis, whereas all patients in our study had ACC. Moreover, while our cohort exclusively consisted of patients who underwent an initial ERCP, the study by Paspatis et al.24 included patients who underwent multiple ERCP sessions. Another difference lies in postprocedural management: whereas Paspatis et al.24 performed follow-up ERCP at 3 to 6 months based on physician discretion, our protocol was to either proceed with stone removal after the resolution of cholangitis or adopt an indefinite stent maintenance strategy.
Third, Paspatis et al.24 focused solely on the incidence of stent migration and did not evaluate other adverse events, such as stent misplacement, stent occlusion, post-ERCP pancreatitis, or bleeding.
Considering these substantial differences, direct comparisons should be interpreted with caution. Nonetheless, our findings suggest that DHPs may represent a potential option for biliary drainage in patients with bile duct stones. In this cohort, more than 20% of the patients had a performance status of 3 or higher, and 20% to 30% were classified with severe cholangitis, indicating that there were many high-risk patients. However, nearly all patients showed clinical improvement following intervention, highlighting the safety and suitability of stent placement without complete stone removal in the first session. Adverse events were comparable to those reported in previous studies and were controllable with treatment.
Stone-related factors, such as large or multiple stones, account for nearly half of the reasons for stent placement. For stones that are difficult to grasp or fragment using ML, early stent placement may be favorable without persistent attempts at complete removal. Stones can be safely removed after clinical improvement. For patients with other risks, such as antithrombotic therapy, severe cholangitis, and ongoing bleeding, stent placement should be prioritized over stone removal.
Additionally, nearly 10% were poor candidates for further endoscopic treatment due to their advanced age or declined performance status, resulting in the adoption of an indefinite stent maintenance strategy. It is often difficult to predict the extent to which a patient’s condition will improve after the first intervention, and whether future interventions will be useful. Our study provides real-world data, implying that approximately 10% of high-risk patients may not be candidates for repetitive interventions. Older patients or those with surgically altered anatomy, multiple bile duct stones, CBD dilation, or steep distal CBD angulation—factors associated with difficult stone removal—should be considered potential candidates for indefinite stent maintenance. Even in patients with indefinite stent maintenance, DHPs may provide advantages over STs for long-term placement, considering the acceptable median potential patency period of 1.5 years.
This study has several limitations as a result of its retrospective design. First, the stent was selected based on operator discretion, resulting in a potential selection bias. Secondly, there are no standardized criteria for determining whether to perform planned stone removal or permanent initial stent placement after stent insertion. Third, the small number of patients with permanent stent placement in both groups may have limited accurate assessment of long-term outcomes. Fourth, candidate factors potentially related to outcomes, such as stone and anatomical factors, were not fully analyzed. Large-scale prospective studies are required to address these limitations.
In conclusion, the efficacy of DHPs was similar to that of the STs in biliary drainage for ACC. DHPs stents exhibited a superior safety profile, making them a potential stent option.
Fig. 1.
Double half-pigtail plastic stent (Double Pit; GADELIUS MEDICAL K.K.). Double half-pigtail plastic stents were preloaded onto the delivery catheter using a threaded connection. Both ends have multiple side holes.
ce-2025-134f1.jpg
Fig. 2.
Patency period of double half-pigtail (DHP) stents and straight plastic stents (ST). The median stent patency period was significantly longer in the DHP stent group (median, 585 days) than in the ST group (median, 247 days) (log-rank test, p<0.01). ST, straight plastic stent; NA, not available.
ce-2025-134f2.jpg
Fig. 3.
Patency period of double half-pigtail plastic stents (DHPs) and straight plastic stent (ST) after propensity score matching. The median stent patency period was significantly longer in the DHP group (median, not reached) than that in the ST group (median, 247 days) (log-rank test, p=0.04). ST, straight plastic stent; NA, not available.
ce-2025-134f3.jpg
ce-2025-134f4.jpg
Table 1.
Baseline characteristics of the 242 patients
Characteristic Double half-pigtail (n=221) Straight (n=21) p-value
Age (yr) 81 (72–87) 83 (78–84) 0.78
Sex (male/female) 107/114 11/10 0.73
Performance status (0/1/2/3/4) 106/38/28/28/21 10/1/3/6/1 0.25
Surgical altered anatomy 27 (12.2) 2 (9.5) 0.72
Severity of cholangitis (mild/moderate/severe) 88/91/42 10/3/8 0.49
Antithrombotic therapy 84 (38.0) 8 (38.1) 0.99
Laboratory data on admission
 Serum WBC (/μL) 9,150 (6,190–13,840) 5,950 (4,490–9,150) 0.03
 Serum CRP (mg/dL) 5.6 (1.6–13.6) 8.9 (1.5–13.7) 0.98
 Serum AST (IU/L) 163 (54–266) 115 (93–338) 0.5
 Serum ALT (IU/L) 142 (67–311) 170 (124–292) 0.02
 Serum total bilirubin (mg/dL) 2.8 (1.2–4.0) 3.7 (1.7–5.1) 0.07

Values are presented as median (interquartile range), number only, or number (%).

WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase.

Table 2.
The details of the initial endoscopic interventions
Double half-pigtail (n=221) Straight (n=21) p-value 95% CI
Endoscopic procedure time (min) 25 (18–48) 31 (20–61) 0.52
EST 136 (61.5) 12 (57.1) 0.69
Endoscopic papillary large balloon dilation 23 (10.4) 1 (4.8) 0.41
Mechanical lithotripter 29 (13.1) 2 (9.5) 0.64
Pero­ral cholangioscopy–assisted EHL 2 (0.9) 2 (9.5) <0.01 0.00–0.89
Pancreatic duct stenting 20 (9.0) 5 (23.8) 0.03 0.08–0.88
No. of CBD stones 2 (1–3) 1 (1–3) 0.31
Maximum stone diameter (mm) 9 (6–14) 7 (5–12) 0.59
Maximum CBD diameter (mm) 12 (9–15) 10 (9–14) 0.7
Distal CBD angulation (degree) 147 (137–157) 148 (141–158) 0.87
Indication for plastic stent placement 0.16
 Stones difficult to remove 115 (52.0) 8 (38.1)
 Anticoagulant therapy 51 (23.1) 5 (23.8)
 Severe cholangitis 24 (10.9) 3 (14.3)
 Post–EST bleeding 22 (10.0) 2 (9.5)
 Deterioration of the general condition during the procedure 9 (4.1) 3 (14.3)
Stent diameter ≥8.5 Fr 5 (2.3) 3 (14.3) <0.01 0.03–0.98

Values are presented as median (interquartile range) or number (%).

CI, confidence interval; EST, endoscopic sphincterotomy; EHL, electrohydraulic lithotripsy; CBD, common bile duct.

Table 3.
Clinical success and adverse events of endoscopic procedures
Double half-pigtail (n=221) Straight (n=21) p-value
Clinical success 219 (99.1) 20 (95.2) 0.13
Adverse events
 Post-ERCP pancreatitis 9 (4.1) 1 (4.8) 0.88
  Mild/moderate/severe 9/0/0 1/0/0
 Post–EST bleeding 16 (7.2) 3 (14.3) 0.25
  Mild/moderate/severe 15/1/0 3/0/0
 Perforation 0 (0) 0 (0) 1.00
 Mortality 0 (0) 0 (0) 1.00

Values are presented as number (%).

ERCP, endoscopic retrograde cholangiopancreatography; EST, endoscopic sphincterotomy.

Table 4.
Risk factors for developing recurrent biliary obstruction after endoscopic interventions
Factors related to the clinical background and course Univariate (p-value) Multivariate (p-value) HR 95% CI
Sex (male) 0.34
Age (≥80 yr) 0.75
Performance status (≥3) 0.46
Surgical altered anatomy (present) 0.26
Severe cholangitis (present) 0.51
Antithrombotic therapy (yes) 0.13 0.11
Serum WBC (≥8,500/μL) 0.24
Serum CRP (≥6 mg/dL) 0.71
Serum AST (≥150 IU/L) 0.39
Serum ALT (≥160 IU/L) 0.63
Serum total bilirubin (≥3 mg/dL) 0.22
Endoscopic procedure time (≥25 min) 0.85
No. of CBD stones (≥5) 0.59
Maximum stone diameter (≥15 mm) 0.11 0.23
Maximum CBD diameter (≥15 mm) 0.54
Distal CBD angulation (≥135 degrees) 0.57
EST (yes) 0.47
Endoscopic papillary large balloon dilation (yes) 0.47
Mechanical lithotripter (yes) 0.51
Peroral cholangioscopy–assisted EHL (yes) 0.73
Pancreatic duct stenting (yes) 0.42
Indication for plastic stent placement: Stones difficult to remove 0.12 0.99
Stent diameter (≥8.5 Fr) 0.28
Stent type (double half-pigtail) <0.01 <0.01 0.25 0.09–0.71
Post-ERCP pancreatitis (present) 0.22
Post–EST bleeding (present) 0.89

HR, hazard ratio; CI, confidence interval; WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; CBD, common bile duct; EST, endoscopic sphincterotomy; EHL, electrohydraulic lithotripsy; ERCP, endoscopic retrograde cholangiopancreatography.

Table 5.
Baseline characteristics and the initial endoscopic interventions after propensity score matching
Characteristic Double half-pigtail (n=17) Straight (n=17) p-value
Age (yr) 84 (76–86) 83 (78–86) 0.76
Sex (male/female) 11/6 9/8 0.73
Performance status (0–2/3–4) 12/5 12/5 1.00
Surgical altered anatomy 1 (5.9) 2 (11.8) 1.00
Severe cholangitis 5 (29.4) 5 (29.4) 1.00
Antithrombotic therapy 9 (52.9) 6 (35.3) 0.49
Laboratory data on admission
 Serum WBC (/μL) 9,930 (7,580–14,960) 8,870 (6,160–13,310) 0.48
 Serum CRP (mg/dL) 7.1 (5.7–12.0) 10.3 (1.5–14.2) 0.93
 Serum AST (IU/L) 170 (92–602) 151 (101–245) 0.82
 Serum ALT (IU/L) 176 (121–308) 159 (95–237) 0.73
 Serum total bilirubin (mg/dL) 2.6 (1.3–4.8) 3.6 (1.7–4.6) 0.71
Endoscopic procedure time (min) 29 (17–54) 30 (20–54) 0.85
EST 9 (52.9) 9 (52.9) 1.00
EPLBD 9 (52.9) 9 (52.9) 1.00
Mechanical lithotripter 9 (52.9) 3 (17.6) 0.07
POCS–assisted EHL 1 (5.9) 0 (0) 1.00
pancreatic duct stenting 2 (11.8) 4 (23.5) 0.66
Number of CBD stones 2 (1–3) 1 (1–3) 0.42
Maximum stone diameter (mm) 11 (9–17) 7 (5–12) 0.11
Maximum CBD diameter (mm) 14 (11–17) 10 (10–14) 0.06
Distal CBD angulation (degree) 155 (145–160) 150 (148–158) 0.86
Indication for plastic stent placement 0.19
 Stones difficult to remove 6 (35.3) 8 (47.1)
 Anticoagulant therapy 4 (23.5) 8 (47.1)
 Severe cholangitis 3 (17.6) 1 (5.9)
 Post–EST bleeding 2 (11.8) 0 (0)
 Deterioration of the general condition during the procedure 2 (11.8) 0 (0)
Stent diameter ≥8.5 Fr 2 (11.8) 3 (17.6) 0.63

Values are presented as median (interquartile range), number only, or number (%).

WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; CBD, common bile duct; EST, endoscopic sphincterotomy; EPLBD, endoscopic papillary large balloon dilation; POCS, peroral cholangioscopy; EHL, electrohydraulic lithotripsy.

Table 6.
Baseline characteristics and the initial endoscopic interventions in indefinite stent maintenance group
Characteristic Indefinite stent maintenance (n=22) Complete stone removal (n=217) p-value
Age (yr) 88 (84–92) 80 (71–86) <0.01
Sex (male/female) 12/10 110/107 0.82
Performance status (0–2/3–4) 13/9 171/46 0.06
Surgical altered anatomy 8 (36.4) 21 (9.7) <0.01
Severe cholangitis 6 (27.3) 44 (20.3) 0.42
Antithrombotic therapy 6 (27.3) 69 (31.8) 0.81
Laboratory data on admission
 Serum WBC (/μL) 9,580 (5,940–13,093) 9,540 (6,490–13,850) 0.46
 Serum CRP (mg/dL) 6.4 (2.1–11.5) 5.7 (1.4–12.8) 0.48
 Serum AST (IU/L) 105 (44–179) 174 (90–355) 0.21
 Serum ALT (IU/L) 146 (36–210) 184 (88–326) 0.09
 Serum total bilirubin (mg/dL) 1.9 (0.7–4.3) 3.0 (1.6–4.6) 0.51
Endoscopic procedure time (min) 35 (19–80) 26 (18–47) 0.15
EST 15 (68.2) 132 (60.8) 0.65
Endoscopic papillary large balloon dilation 15 (68.2) 132 (60.8) 0.65
Mechanical lithotripter 8 (36.4) 90 (41.5) 0.82
Peroral cholangioscopy–assisted EHL 0 (0) 2 (0.9) 1.00
Pancreatic duct stenting 5 (22.7) 20 (9.2) 0.06
No. of CBD stones 3 (1–5) 2 (1–3) 0.02
Maximum stone diameter (mm) 11 (8–17) 9 (5–14) 0.08
Maximum CBD diameter (mm) 14 (12–17) 11 (9–14) <0.01
Distal CBD angulation (degree) 140 (122–148) 148 (138–158) <0.01
Indication for plastic stent placement 0.22
 Stones difficult to remove 16 (72.7) 105 (48.4)
 Anticoagulant therapy 3 (13.6) 52 (24.0)
 Severe cholangitis 2 (9.1) 23 (10.6)
 Post–EST bleeding 0 (0) 24 (11.1)
 Deterioration of the general condition during the procedure 1 (4.5) 11 (5.1)
Stent type (double half-pigtail) 21 (95.5) 198 (91.2) 0.50

Values are presented as median (interquartile range), number only, or number (%).

WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; EST, endoscopic sphincterotomy; EHL, electrohydraulic lithotripsy; CBD, common bile duct.

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        Efficacy of double half-pigtail plastic stents for endoscopic biliary drainage of acute calculous cholangitis
        Clin Endosc. 2025;58(6):898-908.   Published online November 11, 2025
        DOI: https://doi.org/10.5946/ce.2025.134
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      Efficacy of double half-pigtail plastic stents for endoscopic biliary drainage of acute calculous cholangitis
      Image Image Image Image
      Fig. 1. Double half-pigtail plastic stent (Double Pit; GADELIUS MEDICAL K.K.). Double half-pigtail plastic stents were preloaded onto the delivery catheter using a threaded connection. Both ends have multiple side holes.
      Fig. 2. Patency period of double half-pigtail (DHP) stents and straight plastic stents (ST). The median stent patency period was significantly longer in the DHP stent group (median, 585 days) than in the ST group (median, 247 days) (log-rank test, p<0.01). ST, straight plastic stent; NA, not available.
      Fig. 3. Patency period of double half-pigtail plastic stents (DHPs) and straight plastic stent (ST) after propensity score matching. The median stent patency period was significantly longer in the DHP group (median, not reached) than that in the ST group (median, 247 days) (log-rank test, p=0.04). ST, straight plastic stent; NA, not available.
      Graphical abstract

      Fig. 1.

      Fig. 2.

      Fig. 3.

      Graphical abstract

      Efficacy of double half-pigtail plastic stents for endoscopic biliary drainage of acute calculous cholangitis
      Characteristic Double half-pigtail (n=221) Straight (n=21) p-value
      Age (yr) 81 (72–87) 83 (78–84) 0.78
      Sex (male/female) 107/114 11/10 0.73
      Performance status (0/1/2/3/4) 106/38/28/28/21 10/1/3/6/1 0.25
      Surgical altered anatomy 27 (12.2) 2 (9.5) 0.72
      Severity of cholangitis (mild/moderate/severe) 88/91/42 10/3/8 0.49
      Antithrombotic therapy 84 (38.0) 8 (38.1) 0.99
      Laboratory data on admission
       Serum WBC (/μL) 9,150 (6,190–13,840) 5,950 (4,490–9,150) 0.03
       Serum CRP (mg/dL) 5.6 (1.6–13.6) 8.9 (1.5–13.7) 0.98
       Serum AST (IU/L) 163 (54–266) 115 (93–338) 0.5
       Serum ALT (IU/L) 142 (67–311) 170 (124–292) 0.02
       Serum total bilirubin (mg/dL) 2.8 (1.2–4.0) 3.7 (1.7–5.1) 0.07
      Double half-pigtail (n=221) Straight (n=21) p-value 95% CI
      Endoscopic procedure time (min) 25 (18–48) 31 (20–61) 0.52
      EST 136 (61.5) 12 (57.1) 0.69
      Endoscopic papillary large balloon dilation 23 (10.4) 1 (4.8) 0.41
      Mechanical lithotripter 29 (13.1) 2 (9.5) 0.64
      Pero­ral cholangioscopy–assisted EHL 2 (0.9) 2 (9.5) <0.01 0.00–0.89
      Pancreatic duct stenting 20 (9.0) 5 (23.8) 0.03 0.08–0.88
      No. of CBD stones 2 (1–3) 1 (1–3) 0.31
      Maximum stone diameter (mm) 9 (6–14) 7 (5–12) 0.59
      Maximum CBD diameter (mm) 12 (9–15) 10 (9–14) 0.7
      Distal CBD angulation (degree) 147 (137–157) 148 (141–158) 0.87
      Indication for plastic stent placement 0.16
       Stones difficult to remove 115 (52.0) 8 (38.1)
       Anticoagulant therapy 51 (23.1) 5 (23.8)
       Severe cholangitis 24 (10.9) 3 (14.3)
       Post–EST bleeding 22 (10.0) 2 (9.5)
       Deterioration of the general condition during the procedure 9 (4.1) 3 (14.3)
      Stent diameter ≥8.5 Fr 5 (2.3) 3 (14.3) <0.01 0.03–0.98
      Double half-pigtail (n=221) Straight (n=21) p-value
      Clinical success 219 (99.1) 20 (95.2) 0.13
      Adverse events
       Post-ERCP pancreatitis 9 (4.1) 1 (4.8) 0.88
        Mild/moderate/severe 9/0/0 1/0/0
       Post–EST bleeding 16 (7.2) 3 (14.3) 0.25
        Mild/moderate/severe 15/1/0 3/0/0
       Perforation 0 (0) 0 (0) 1.00
       Mortality 0 (0) 0 (0) 1.00
      Factors related to the clinical background and course Univariate (p-value) Multivariate (p-value) HR 95% CI
      Sex (male) 0.34
      Age (≥80 yr) 0.75
      Performance status (≥3) 0.46
      Surgical altered anatomy (present) 0.26
      Severe cholangitis (present) 0.51
      Antithrombotic therapy (yes) 0.13 0.11
      Serum WBC (≥8,500/μL) 0.24
      Serum CRP (≥6 mg/dL) 0.71
      Serum AST (≥150 IU/L) 0.39
      Serum ALT (≥160 IU/L) 0.63
      Serum total bilirubin (≥3 mg/dL) 0.22
      Endoscopic procedure time (≥25 min) 0.85
      No. of CBD stones (≥5) 0.59
      Maximum stone diameter (≥15 mm) 0.11 0.23
      Maximum CBD diameter (≥15 mm) 0.54
      Distal CBD angulation (≥135 degrees) 0.57
      EST (yes) 0.47
      Endoscopic papillary large balloon dilation (yes) 0.47
      Mechanical lithotripter (yes) 0.51
      Peroral cholangioscopy–assisted EHL (yes) 0.73
      Pancreatic duct stenting (yes) 0.42
      Indication for plastic stent placement: Stones difficult to remove 0.12 0.99
      Stent diameter (≥8.5 Fr) 0.28
      Stent type (double half-pigtail) <0.01 <0.01 0.25 0.09–0.71
      Post-ERCP pancreatitis (present) 0.22
      Post–EST bleeding (present) 0.89
      Characteristic Double half-pigtail (n=17) Straight (n=17) p-value
      Age (yr) 84 (76–86) 83 (78–86) 0.76
      Sex (male/female) 11/6 9/8 0.73
      Performance status (0–2/3–4) 12/5 12/5 1.00
      Surgical altered anatomy 1 (5.9) 2 (11.8) 1.00
      Severe cholangitis 5 (29.4) 5 (29.4) 1.00
      Antithrombotic therapy 9 (52.9) 6 (35.3) 0.49
      Laboratory data on admission
       Serum WBC (/μL) 9,930 (7,580–14,960) 8,870 (6,160–13,310) 0.48
       Serum CRP (mg/dL) 7.1 (5.7–12.0) 10.3 (1.5–14.2) 0.93
       Serum AST (IU/L) 170 (92–602) 151 (101–245) 0.82
       Serum ALT (IU/L) 176 (121–308) 159 (95–237) 0.73
       Serum total bilirubin (mg/dL) 2.6 (1.3–4.8) 3.6 (1.7–4.6) 0.71
      Endoscopic procedure time (min) 29 (17–54) 30 (20–54) 0.85
      EST 9 (52.9) 9 (52.9) 1.00
      EPLBD 9 (52.9) 9 (52.9) 1.00
      Mechanical lithotripter 9 (52.9) 3 (17.6) 0.07
      POCS–assisted EHL 1 (5.9) 0 (0) 1.00
      pancreatic duct stenting 2 (11.8) 4 (23.5) 0.66
      Number of CBD stones 2 (1–3) 1 (1–3) 0.42
      Maximum stone diameter (mm) 11 (9–17) 7 (5–12) 0.11
      Maximum CBD diameter (mm) 14 (11–17) 10 (10–14) 0.06
      Distal CBD angulation (degree) 155 (145–160) 150 (148–158) 0.86
      Indication for plastic stent placement 0.19
       Stones difficult to remove 6 (35.3) 8 (47.1)
       Anticoagulant therapy 4 (23.5) 8 (47.1)
       Severe cholangitis 3 (17.6) 1 (5.9)
       Post–EST bleeding 2 (11.8) 0 (0)
       Deterioration of the general condition during the procedure 2 (11.8) 0 (0)
      Stent diameter ≥8.5 Fr 2 (11.8) 3 (17.6) 0.63
      Characteristic Indefinite stent maintenance (n=22) Complete stone removal (n=217) p-value
      Age (yr) 88 (84–92) 80 (71–86) <0.01
      Sex (male/female) 12/10 110/107 0.82
      Performance status (0–2/3–4) 13/9 171/46 0.06
      Surgical altered anatomy 8 (36.4) 21 (9.7) <0.01
      Severe cholangitis 6 (27.3) 44 (20.3) 0.42
      Antithrombotic therapy 6 (27.3) 69 (31.8) 0.81
      Laboratory data on admission
       Serum WBC (/μL) 9,580 (5,940–13,093) 9,540 (6,490–13,850) 0.46
       Serum CRP (mg/dL) 6.4 (2.1–11.5) 5.7 (1.4–12.8) 0.48
       Serum AST (IU/L) 105 (44–179) 174 (90–355) 0.21
       Serum ALT (IU/L) 146 (36–210) 184 (88–326) 0.09
       Serum total bilirubin (mg/dL) 1.9 (0.7–4.3) 3.0 (1.6–4.6) 0.51
      Endoscopic procedure time (min) 35 (19–80) 26 (18–47) 0.15
      EST 15 (68.2) 132 (60.8) 0.65
      Endoscopic papillary large balloon dilation 15 (68.2) 132 (60.8) 0.65
      Mechanical lithotripter 8 (36.4) 90 (41.5) 0.82
      Peroral cholangioscopy–assisted EHL 0 (0) 2 (0.9) 1.00
      Pancreatic duct stenting 5 (22.7) 20 (9.2) 0.06
      No. of CBD stones 3 (1–5) 2 (1–3) 0.02
      Maximum stone diameter (mm) 11 (8–17) 9 (5–14) 0.08
      Maximum CBD diameter (mm) 14 (12–17) 11 (9–14) <0.01
      Distal CBD angulation (degree) 140 (122–148) 148 (138–158) <0.01
      Indication for plastic stent placement 0.22
       Stones difficult to remove 16 (72.7) 105 (48.4)
       Anticoagulant therapy 3 (13.6) 52 (24.0)
       Severe cholangitis 2 (9.1) 23 (10.6)
       Post–EST bleeding 0 (0) 24 (11.1)
       Deterioration of the general condition during the procedure 1 (4.5) 11 (5.1)
      Stent type (double half-pigtail) 21 (95.5) 198 (91.2) 0.50
      Table 1. Baseline characteristics of the 242 patients

      Values are presented as median (interquartile range), number only, or number (%).

      WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase.

      Table 2. The details of the initial endoscopic interventions

      Values are presented as median (interquartile range) or number (%).

      CI, confidence interval; EST, endoscopic sphincterotomy; EHL, electrohydraulic lithotripsy; CBD, common bile duct.

      Table 3. Clinical success and adverse events of endoscopic procedures

      Values are presented as number (%).

      ERCP, endoscopic retrograde cholangiopancreatography; EST, endoscopic sphincterotomy.

      Table 4. Risk factors for developing recurrent biliary obstruction after endoscopic interventions

      HR, hazard ratio; CI, confidence interval; WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; CBD, common bile duct; EST, endoscopic sphincterotomy; EHL, electrohydraulic lithotripsy; ERCP, endoscopic retrograde cholangiopancreatography.

      Table 5. Baseline characteristics and the initial endoscopic interventions after propensity score matching

      Values are presented as median (interquartile range), number only, or number (%).

      WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; CBD, common bile duct; EST, endoscopic sphincterotomy; EPLBD, endoscopic papillary large balloon dilation; POCS, peroral cholangioscopy; EHL, electrohydraulic lithotripsy.

      Table 6. Baseline characteristics and the initial endoscopic interventions in indefinite stent maintenance group

      Values are presented as median (interquartile range), number only, or number (%).

      WBC, white blood cell count; CRP, C-reactive protein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; EST, endoscopic sphincterotomy; EHL, electrohydraulic lithotripsy; CBD, common bile duct.

      Table 1.

      Table 2.

      Table 3.

      Table 4.

      Table 5.

      Table 6.

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