1Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore
2Medicine Academic Clinical Programme (MedACP), Duke-NUS Medical School, Singapore, Singapore
© 2024 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.
Conflicts of Interest
Damien Meng Yew Tan is a consultant for Boston Scientific and Pentax Medical. The other authors declare no potential conflicts of interest.
Funding
None.
Acknowledgments
The authors thank Medtronic for providing the GI Genius endoscopy module. Additionally, we extend our heartfelt thanks to the doctors and endoscopy nurses in the Department of Gastrointestinal Surgery at the University Hospital of Southern Denmark whose support and cooperation greatly facilitated the successful completion of this research project.
Author Contributions
Conceptualization: all authors; Data curation: all authors; Formal analysis: all authors; Project administration: all authors; Supervision: DMYT; Writing–original draft: all authors; Writing–review & editing: all authors.
All needles are in 19-G size. Adapted from Mauna Kea Technologies, France.14
Study | Year | Study design | Country | Accuracy rate of EUS-nCLE | Basis of final diagnosis | n | Sex (male/female) | Age (mean in years) | Size (mm) |
---|---|---|---|---|---|---|---|---|---|
Konda et al.15 | 2011 | Prospective study | United States | Safety and feasibility study | Histology | 18 | 7/11 | 57.9 | 43 |
Cytology | |||||||||
Imaging on EUS | |||||||||
Konda et al.16 (INSPECT) | 2013 | Retrospective study | United States | 71% | Clinical consensus | 31 | 15/16 | 59.7 | 32 |
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Follow-up imaging | |||||||||
Nakai et al.17 (DETECT) | 2015 | Prospective study | United States | 89% | Histology | 30 | 9/21 | 72 | 30 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Napoleon et al.18 (CONTACT 1) | 2016 | Prospective study | France | 87% | Clinical consensus | 31 | 6/25 | 57 | 39 |
Histology | |||||||||
Cytology | |||||||||
Karia et al.23 | 2016 | Retrospective study | United States | 46% | Histology | 15 | 10/5 | 66.6 | 25 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Krishna et al.24 | 2016 | Retrospective study | United States | 95% | Clinical consensus | 26 | 10/16 | 54.8 | 32 |
Histology | |||||||||
Cytology | |||||||||
Kadayifci et al.22 | 2017 | Retrospective study | United States | 83% | Histology | 18 | 8/10 | 65.4 | 34 |
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Krishna et al.25 | 2017 | Retrospective study | United States | 95% | Clinical consensus | 29 | 13/16 | 53 | 32 |
· Histology | |||||||||
Napoleon et al.20 (CONTACT 2) | 2019 | Prospective study | France | 91% | Histology | 78 | 26/52 | 57 | 40 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Chin et al.19 | 2018 | Prospective study | Singapore | 80% | Histology | 12 | 6/6 | 66.5 | 34 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Keane et al.21 (CONCYST-01) | 2019 | Prospective study | United Kingdom | 77% | Clinical consensus | 56 | 35/21 | 68 | 25 |
Cytology | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Palazzo et al.26 | 2020 | Retrospective study | France | 85% | Clinical consensus | 206 | 69/137 | 57 | 38 |
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Cheesman et al.27 | 2020 | Retrospective study | United States | 84% | Histology | 44 | 16/28 | 66 | 34 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging |
nCLE, needle-based confocal laser endomicroscopy; EUS, endoscopic ultrasound; PCF, pancreatic cystic fluid; INSPECT, in vivo nCLE study in the pancreas with endosonography of cystic tumors; DETECT, Diagnosis of pancreatic cysts: endoscopic ultrasound, through-the-needle confocal laser endomicroscopy and cystoscopy trial; CONCYST-01, Confocal endomicroscopy in cystic lesions of the pancreas.
Pattern | Study | Year | n | Sensitivity (%) | Specificity (%) | Accuracy (%) |
---|---|---|---|---|---|---|
Serous cystadenoma | ||||||
Fern pattern | Krishna et al.25 | 2017 | 13 | 98 | 97 | 92 |
Fern pattern | Krishna et al.29 | 2020 | 113 | 87 | 100 | 97 |
Superficial vascular network | Napoléon et al.28 | 2015 | 31 | 69 | 100 | 87 |
Superficial vascular network | Napoleon et al.20 | 2019 | 71 | 95 | 100 | 99 |
Superficial vascular network | Keane et al.21 | 2019 | 56 | 56 | - | 38 |
Pseudocyst | ||||||
Bright particles on a dark background | Napoleon et al.18 | 2016 | 31 | 43 | 100 | 87 |
Bright particles on a dark background | Krishna et al.29 | 2020 | 65 | 67 | 97 | 95 |
A field of bright, grey, and black particles | Keane et al.21 | 2019 | 56 | 67 | - | 67 |
IPMN | ||||||
Papillae with finger-like projections | Nakai et al.17 | 2015 | 30 | 77 | 100 | 87 |
Papillae with finger-like projections | Napoleon et al.18 | 2016 | 31 | 80 | 92 | 90 |
Papillae with finger-like projections | Krishna et al.29 | 2020 | 65 | 98 | 94 | 97 |
Papillae with finger-like projections | Keane et al.21 | 2019 | 56 | 90 | - | 77 |
MCN | ||||||
Epithelial bands | Napoleon et al.18 | 2016 | 31 | 67 | 96 | 90 |
Epithelial bands | Krishna et al.29 | 2020 | 65 | 98 | 94 | 97 |
Mucinous cyst (both IPMN and MCN) | ||||||
Papillae with finger-like projections or epithelial bands | Krishna et al.30 | 2015 | 33 | 91 | 95 | 94 |
Krishna et al.24 | 2016 | 26 | 94 | 82 | 89 | |
Napoleon et al.20 | 2019 | 71 | 95 | 100 | 97 | |
Papillae with finger-like projections, or dark rings, or gland-like structures, or epithelial bands | Kadayifci et al.22 | 2017 | 18 | 66 | 100 | 83 |
Rope ladder, or branch vascular pattern, or papillae with finger-like projections, or epithelial bands | Krishna et al.25 | 2017 | 16 | 93 | 89 | 91 |
Neuroendocrine neoplasm | ||||||
Trabeculae of compact cells surrounded by grey tissue | Krishna et al.25 | 2017 | 13 | 98 | 97 | 92 |
Krishna et al.29 | 2020 | 65 | 100 | 96 | 96 | |
Napoleon et al.20 | 2019 | 71 | 100 | 95 | 96 |
nCLE, needle-based confocal laser endomicroscopy; IPMN, intraductal papillary mucinous neoplasm; MCN, mucinous cystic neoplasm; -, The authors did not comment on the specificity of nCLE diagnostic features for specific pathology, and the number of false positive and true negative cases was not available.
Study | Year | n | Complications | |||||
---|---|---|---|---|---|---|---|---|
Pancreatitis | Bleeding | Infection | Fluorescein-related | Death | Overall | |||
Konda et al.15 | 2011 | 18 | 2 (11.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (11.1) |
Konda et al.16 | 2013 | 66 | 2 (3.0) | 3 (4.5) | 0 (0) | 0 (0) | 0 (0) | 6 (9.1) |
Nakai et al.17 | 2015 | 30 | 2 (6.7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (6.7) |
Napoleon et al.28 | 2015 | 31 | 1 (3.2) | 4 (12.9) | 0 (0) | 0 (0) | 0 (0) | 5 (16.1) |
Krishna et al.24 | 2016 | 49 | 3 (6.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (6.1) |
Chin et al.19 | 2018 | 12 | 0 (0) | 1 (8.3) | 0 (0) | 0 (0) | 0 (0) | 1 (8.3) |
Napoleon et al.20 | 2019 | 78 | 1 (1.3) | 1 (1.3) | 0 (0) | 0 (0) | 0 (0) | 2 (2.6) |
Keane et al.21 | 2019 | 56 | 0 (0) | 0 (0) | 1 (1.8) | 1 (1.8) | 0 (0) | 2 (3.6) |
Palazzo et al.26 | 2020 | 209 | 3 (1.4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (1.4) |
Cheesman et al.27 | 2020 | 44 | 0 (0) | 0 (0) | 1 (2.3) | 0 (0) | 0 (0) | 1 (2.3) |
Overall | 593 | 14 (2.4) | 9 (1.5) | 2 (0.3) | 1 (0.2) | 0 (0.0) | 28 (4.7) |
Type of needle | Manufacturer | Compatible |
---|---|---|
EchoTip Ultra Endoscopic Ultrasound Needle | Cook Medical | Yes |
EZShot 2 Aspiration Needle | Olympus | Yes |
Expect Needle 19 Flex | Boston Scientific | Yes |
SonoTip Pro Control | Medi-Globe Gmbh | Yes |
SonoTip II | Medi-Globe Gmbh | Yes |
BNX Fine Needle Aspiration System | Medtronic | Yes |
EchoTip Ultra Endoscopic Ultrasound Access Needle | Cook Medical | No |
EchoTip ProCore | Cook Medical | No |
Quick-Core Endoscopic Ultrasound Needle | Cook Medical | No |
19-G FlexNeedle Clearview | CONMED | No |
Study | Year | Study design | Country | Accuracy rate of EUS-nCLE | Basis of final diagnosis | n | Sex (male/female) | Age (mean in years) | Size (mm) |
---|---|---|---|---|---|---|---|---|---|
Konda et al.15 | 2011 | Prospective study | United States | Safety and feasibility study | Histology | 18 | 7/11 | 57.9 | 43 |
Cytology | |||||||||
Imaging on EUS | |||||||||
Konda et al.16 (INSPECT) | 2013 | Retrospective study | United States | 71% | Clinical consensus | 31 | 15/16 | 59.7 | 32 |
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Follow-up imaging | |||||||||
Nakai et al.17 (DETECT) | 2015 | Prospective study | United States | 89% | Histology | 30 | 9/21 | 72 | 30 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Napoleon et al.18 (CONTACT 1) | 2016 | Prospective study | France | 87% | Clinical consensus | 31 | 6/25 | 57 | 39 |
Histology | |||||||||
Cytology | |||||||||
Karia et al.23 | 2016 | Retrospective study | United States | 46% | Histology | 15 | 10/5 | 66.6 | 25 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Krishna et al.24 | 2016 | Retrospective study | United States | 95% | Clinical consensus | 26 | 10/16 | 54.8 | 32 |
Histology | |||||||||
Cytology | |||||||||
Kadayifci et al.22 | 2017 | Retrospective study | United States | 83% | Histology | 18 | 8/10 | 65.4 | 34 |
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Krishna et al.25 | 2017 | Retrospective study | United States | 95% | Clinical consensus | 29 | 13/16 | 53 | 32 |
· Histology | |||||||||
Napoleon et al.20 (CONTACT 2) | 2019 | Prospective study | France | 91% | Histology | 78 | 26/52 | 57 | 40 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Chin et al.19 | 2018 | Prospective study | Singapore | 80% | Histology | 12 | 6/6 | 66.5 | 34 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Keane et al.21 (CONCYST-01) | 2019 | Prospective study | United Kingdom | 77% | Clinical consensus | 56 | 35/21 | 68 | 25 |
Cytology | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Palazzo et al.26 | 2020 | Retrospective study | France | 85% | Clinical consensus | 206 | 69/137 | 57 | 38 |
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging | |||||||||
Cheesman et al.27 | 2020 | Retrospective study | United States | 84% | Histology | 44 | 16/28 | 66 | 34 |
Cytology | |||||||||
PCF analysis | |||||||||
Imaging on EUS | |||||||||
Cross-sectional imaging |
Pattern | Study | Year | n | Sensitivity (%) | Specificity (%) | Accuracy (%) |
---|---|---|---|---|---|---|
Serous cystadenoma | ||||||
Fern pattern | Krishna et al.25 | 2017 | 13 | 98 | 97 | 92 |
Fern pattern | Krishna et al.29 | 2020 | 113 | 87 | 100 | 97 |
Superficial vascular network | Napoléon et al.28 | 2015 | 31 | 69 | 100 | 87 |
Superficial vascular network | Napoleon et al.20 | 2019 | 71 | 95 | 100 | 99 |
Superficial vascular network | Keane et al.21 | 2019 | 56 | 56 | - | 38 |
Pseudocyst | ||||||
Bright particles on a dark background | Napoleon et al.18 | 2016 | 31 | 43 | 100 | 87 |
Bright particles on a dark background | Krishna et al.29 | 2020 | 65 | 67 | 97 | 95 |
A field of bright, grey, and black particles | Keane et al.21 | 2019 | 56 | 67 | - | 67 |
IPMN | ||||||
Papillae with finger-like projections | Nakai et al.17 | 2015 | 30 | 77 | 100 | 87 |
Papillae with finger-like projections | Napoleon et al.18 | 2016 | 31 | 80 | 92 | 90 |
Papillae with finger-like projections | Krishna et al.29 | 2020 | 65 | 98 | 94 | 97 |
Papillae with finger-like projections | Keane et al.21 | 2019 | 56 | 90 | - | 77 |
MCN | ||||||
Epithelial bands | Napoleon et al.18 | 2016 | 31 | 67 | 96 | 90 |
Epithelial bands | Krishna et al.29 | 2020 | 65 | 98 | 94 | 97 |
Mucinous cyst (both IPMN and MCN) | ||||||
Papillae with finger-like projections or epithelial bands | Krishna et al.30 | 2015 | 33 | 91 | 95 | 94 |
Krishna et al.24 | 2016 | 26 | 94 | 82 | 89 | |
Napoleon et al.20 | 2019 | 71 | 95 | 100 | 97 | |
Papillae with finger-like projections, or dark rings, or gland-like structures, or epithelial bands | Kadayifci et al.22 | 2017 | 18 | 66 | 100 | 83 |
Rope ladder, or branch vascular pattern, or papillae with finger-like projections, or epithelial bands | Krishna et al.25 | 2017 | 16 | 93 | 89 | 91 |
Neuroendocrine neoplasm | ||||||
Trabeculae of compact cells surrounded by grey tissue | Krishna et al.25 | 2017 | 13 | 98 | 97 | 92 |
Krishna et al.29 | 2020 | 65 | 100 | 96 | 96 | |
Napoleon et al.20 | 2019 | 71 | 100 | 95 | 96 |
Study | Year | n | Complications | |||||
---|---|---|---|---|---|---|---|---|
Pancreatitis | Bleeding | Infection | Fluorescein-related | Death | Overall | |||
Konda et al.15 | 2011 | 18 | 2 (11.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (11.1) |
Konda et al.16 | 2013 | 66 | 2 (3.0) | 3 (4.5) | 0 (0) | 0 (0) | 0 (0) | 6 (9.1) |
Nakai et al.17 | 2015 | 30 | 2 (6.7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (6.7) |
Napoleon et al.28 | 2015 | 31 | 1 (3.2) | 4 (12.9) | 0 (0) | 0 (0) | 0 (0) | 5 (16.1) |
Krishna et al.24 | 2016 | 49 | 3 (6.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (6.1) |
Chin et al.19 | 2018 | 12 | 0 (0) | 1 (8.3) | 0 (0) | 0 (0) | 0 (0) | 1 (8.3) |
Napoleon et al.20 | 2019 | 78 | 1 (1.3) | 1 (1.3) | 0 (0) | 0 (0) | 0 (0) | 2 (2.6) |
Keane et al.21 | 2019 | 56 | 0 (0) | 0 (0) | 1 (1.8) | 1 (1.8) | 0 (0) | 2 (3.6) |
Palazzo et al.26 | 2020 | 209 | 3 (1.4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (1.4) |
Cheesman et al.27 | 2020 | 44 | 0 (0) | 0 (0) | 1 (2.3) | 0 (0) | 0 (0) | 1 (2.3) |
Overall | 593 | 14 (2.4) | 9 (1.5) | 2 (0.3) | 1 (0.2) | 0 (0.0) | 28 (4.7) |
All needles are in 19-G size. Adapted from Mauna Kea Technologies, France.
nCLE, needle-based confocal laser endomicroscopy; EUS, endoscopic ultrasound; PCF, pancreatic cystic fluid; INSPECT,
nCLE, needle-based confocal laser endomicroscopy; IPMN, intraductal papillary mucinous neoplasm; MCN, mucinous cystic neoplasm; -, The authors did not comment on the specificity of nCLE diagnostic features for specific pathology, and the number of false positive and true negative cases was not available.
Values are presented as number (%).