Download PDF
Endoscopy 2020; 52(07): 574-582
DOI: 10.1055/a-1135-8980
Original article

Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry

Majid A. Almadi
 1   King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia
,
Takao Itoi
 2   Tokyo Medical University, Tokyo, Japan
,
Jong Ho Moon
 3   Soon Chun Hyang University Hospital, Seoul, Republic of Korea
,
Mahesh K. Goenka
 4   Apollo Gleneagles Hospital, Kolkata, India
,
Dong Wan Seo
 5   Asan Medical Center, Seoul, Republic of Korea
,
Rungsun Rerknimitr
 6   Chulalongkorn University, Bangkok, Thailand
,
James Y. Lau
 7   Prince of Wales Hospital, Shatin, Hong Kong
,
Amit P. Maydeo
 8   Baldota Institute of Digestive Sciences, Mumbai, Maharashtra, India
,
Jong Kyun Lee
 9   Samsung Medical Center, Seoul, Republic of Korea
,
Nam Q. Nguyen
10   Royal Adelaide Hospital, Adelaide, Australia
,
Saad K. Niaz
11   Civil Hospital, Karachi, Karachi, Pakistan
,
Randhir Sud
12   Medanta, The Mediciti, Gurgaon, India
,
Tiing Leong Ang
13   Changi General Hospital, Singapore, Singapore
,
Abdulrahman Aljebreen
 1   King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia
,
Benedict M. Devereaux
14   University of Queensland Medical School, Brisbane, Australia
,
Rakesh Kochhar
15   Postgraduate Institute of Medical Education and Research, Chandigarh, India
,
Jörg Reichenberger
16   Netcare Unitas, Centurion, South Africa
,
Ichiro Yasuda
17   Teikyo University Mizonokuchi Hospital, Kawasaki, Japan
,
Arthur J. Kaffes
18   Royal Prince Alfred Hospital, Sydney, Australia
,
Masayuki Kitano
19   Kindai University, Osaka, Japan
,
Joyce Peetermans
20   Boston Scientific Corporation, Marlborough, Massachusetts, USA
,
Pooja G. Goswamy
20   Boston Scientific Corporation, Marlborough, Massachusetts, USA
,
Matthew J. Rousseau
20   Boston Scientific Corporation, Marlborough, Massachusetts, USA
,
D. Nageshwar Reddy
21   Asian Institute of Gastroenterology, Hyderabad, India
,
Sundeep Lakhtakia
21   Asian Institute of Gastroenterology, Hyderabad, India
,
Yun Nah Lee
 3   Soon Chun Hyang University Hospital, Seoul, Republic of Korea
,
Vijay Kumar Rai
 4   Apollo Gleneagles Hospital, Kolkata, India
,
Kentaro Kamada
 2   Tokyo Medical University, Tokyo, Japan
,
Reina Tanaka
 2   Tokyo Medical University, Tokyo, Japan
,
Ryosuke Tonozuka
 2   Tokyo Medical University, Tokyo, Japan
,
Akihiko Tsuchida
 2   Tokyo Medical University, Tokyo, Japan
,
Tae Jun Song
 5   Asan Medical Center, Seoul, Republic of Korea
,
Mohan K. Ramchandani
21   Asian Institute of Gastroenterology, Hyderabad, India
,
and the SpyGlass AMEA Registry Group › Author Affiliations
› Further Information
Also available at
    Permissions and Reprints

Referred to by:

Single-operator cholangioscopy: more good numbers, with a few caveatsEndoscopy 2020; 52(07): 533-534
DOI: 10.1055/a-1172-9933

Abstract

Background Peroral cholangioscopy (POCS) of indeterminate biliary strictures aims to achieve a diagnosis through visual examination and/or by obtaining targeted biopsies under direct visualization. In this large, prospective, multinational, real-life experience of POCS-guided evaluation of indeterminate biliary strictures, we evaluated the performance of POCS in this difficult-to-manage patient population.

Methods This prospective registry enrolled patients, with indeterminate biliary strictures across 20 centers in Asia, the Middle East, and Africa. The primary end points were the ability to visualize the lesion, obtain histological sampling when intended, and an assessment of the diagnostic accuracy of POCS for malignant strictures. Patients were followed for 6 months after POCS or until a definitive malignant diagnosis was made, whichever occurred first.

Results 289 patients underwent 290 POCS procedures with intent to biopsy in 182 cases. The stricture/filling defect was successfully visualized in 286/290 (98.6 %), providing a visual diagnostic impression in 253/290 (87.2 %) and obtaining adequate biopsies in 169/182 (92.9 %). Procedure-related adverse events occurred in 5/289 patients (1.7 %). POCS influenced patient management principally by elucidating filling defects or the causes of bile duct stricture or dilation. The visual impression of malignancy showed 86.7 % sensitivity, 71.2 % specificity, 65.8 % positive and 89.4 % negative predictive value, and 77.2 % overall accuracy compared with final diagnosis. Histological POCS-guided samples showed 75.3 % sensitivity, 100 % specificity, 100 % positive and 77.1 % negative predictive value, and 86.5 % overall accuracy.

Conclusion In this large, real-life, prospective series, POCS was demonstrated to be an effective and safe intervention guiding the management of patients with indeterminate biliary strictures.



Publication History

Received: 05 December 2019

Accepted: 19 February 2020

Article published online:
14 April 2020

© Georg Thieme Verlag KG
Stuttgart · New York

Refers to:

Author commentary on Majid A. Almadi et al.Endoscopy 2020; 52(07): v27-v27
DOI: 10.1055/a-1160-0439

 

  • References

  • 1 Tsou YK, Lin CH, Tang JH. et al. Direct peroral cholangioscopy using an ultraslim endoscope and overtube balloon-assisted technique: a case series. Endoscopy 2010; 42: 681-684
    Article in Thieme ConnectPubMedGoogle Scholar
  • 2 Farnik H, Weigt J, Malfertheiner P. et al. A multicenter study on the role of direct retrograde cholangioscopy in patients with inconclusive endoscopic retrograde cholangiography. Endoscopy 2014; 46: 16-21
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Du L, D'Souza P, Thiesen A. et al. Percutaneous transhepatic cholangioscopy for indeterminate biliary strictures using the SpyGlass system: a case series. Endoscopy 2015; 47: 1054-1056
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 Chen YK. Preclinical characterization of the Spyglass peroral cholangiopancreatoscopy system for direct access, visualization, and biopsy. Gastrointest Endosc 2007; 65: 303-311
    CrossrefPubMedGoogle Scholar
  • 5 Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc 2007; 65: 832-841
    CrossrefPubMedGoogle Scholar
  • 6 Chen YK, Parsi MA, Binmoeller KF. et al. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc 2011; 74: 805-814
    CrossrefPubMedGoogle Scholar
  • 7 Maydeo AP, Rerknimitr R, Lau JY. et al. Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates. Endoscopy 2019; DOI: 10.1055/a-0942-9336.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 8 Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017. http://www.healthdata.org/policy-report/findings-global-burden-disease-study-2017 Available from (Accessed 04.03.2020):
    PubMedGoogle Scholar
  • 9 Schwarzer R, Rochau U, Saverno K. et al. Systematic overview of cost-effectiveness thresholds in ten countries across four continents. J Comp Eff Res 2015; 4: 485-504
    CrossrefPubMedGoogle Scholar
  • 10 Culyer AJ. Cost-effectiveness thresholds: a comment on the commentaries. Health Econ Policy Law 2016; 11: 445-447
    CrossrefPubMedGoogle Scholar
  • 11 Bowlus CL, Olson KA, Gershwin ME. Evaluation of indeterminate biliary strictures. Nat Rev Gastroenterol Hepatol 2016; 13: 28-37
    PubMedGoogle Scholar
  • 12 Navaneethan U, Njei B, Lourdusamy V. et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc 2015; 81: 168-176
    CrossrefPubMedGoogle Scholar
  • 13 Pons Beltran V, Alonso-Lazaro N, Mansilla-Vivar R. et al. Single-operator cholangiopancreatoscopy in pancreatobiliary diseases: clinical experience in a tertiary referral hospital. Rev Esp Enferm Dig 2018; 110: 748-754
    PubMedGoogle Scholar
  • 14 Navaneethan U, Njeim B. Response. Gastrointest Endosc 2015; 82: 1137
    PubMedGoogle Scholar
  • 15 Navaneethan U, Hasan MK, Kommaraju K. et al. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc 2016; 84: 649-655
    CrossrefPubMedGoogle Scholar
  • 16 Varadarajulu S, Bang JY, Hasan MK. et al. Improving the diagnostic yield of single-operator cholangioscopy-guided biopsy of indeterminate biliary strictures: ROSE to the rescue? (with video). Gastrointest Endosc 2016; 84: 681-687
    CrossrefPubMedGoogle Scholar
  • 17 Kurihara T, Yasuda I, Isayama H. et al. Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan. World J Gastroenterol 2016; 22: 1891-1901
    CrossrefPubMedGoogle Scholar
  • 18 ASGE TechnologyCommittee, Komanduri S, Thosani N. et al. Cholangiopancreatoscopy. Gastrointest Endosc 2016; 84: 209-221
    CrossrefPubMedGoogle Scholar
  • 19 Lee JG. Diagnosis and management of acute cholangitis. Nat Rev Gastroenterol Hepatol 2009; 6: 533-541
    PubMedGoogle Scholar
  • 20 Ang TL, Kwek ABE. Safety and efficacy of SpyGlass cholangiopancreatoscopy in routine clinical practice in a regional Singapore hospital. Singapore Med J 2019; 60: 538-544
    CrossrefPubMedGoogle Scholar
  • 21 Sethi A, Doukides T, Sejpal DV. et al. Interobserver agreement for single operator choledochoscopy imaging: can we do better?. Diagn Ther Endosc 2014; 2014: 730731
    PubMedGoogle Scholar
  • 22 Cotton PB, Eisen G, Romagnuolo J. et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc 2011; 73: 868-874
    CrossrefPubMedGoogle Scholar
  • 23 Kalaitzakis E, Webster GJ, Oppong KW. et al. Diagnostic and therapeutic utility of single-operator peroral cholangioscopy for indeterminate biliary lesions and bile duct stones. Eur J Gastroenterol Hepatol 2012; 24: 656-664
    CrossrefPubMedGoogle Scholar
  • 24 Laleman W, Verraes K, Van Steenbergen W. et al. Usefulness of the single-operator cholangioscopy system SpyGlass in biliary disease: a single-center prospective cohort study and aggregated review. Surg Endosc 2017; 31: 2223-2232
    CrossrefPubMedGoogle Scholar
  • 25 Bang JY, Navaneethan U, Hasan M. et al. Optimizing outcomes of single-operator cholangioscopy-guided biopsies: results of a randomized trial. Clin Gastroenterol Hepatol 2020; 18: 441-448.e1
    CrossrefPubMedGoogle Scholar
  • 26 Mounzer R, Austin GL, Wani S. et al. Per-oral video cholangiopancreatoscopy with narrow-band imaging for the evaluation of indeterminate pancreaticobiliary disease. Gastrointest Endosc 2017; 85: 509-517
    CrossrefPubMedGoogle Scholar
  • 27 de Vries AB, van der Heide F, Ter Steege RWF. et al. Limited diagnostic accuracy and clinical impact of single-operator peroral cholangioscopy for indeterminate biliary strictures. Endoscopy 2020; 52: 107-114
    Article in Thieme ConnectPubMedGoogle Scholar
  • 28 de Moura EGH. Limited diagnostic accuracy and clinical impact of single-operator peroral cholangioscopy for indeterminate biliary strictures. Endoscopy 2020; 52: 90-91
    Article in Thieme ConnectPubMedGoogle Scholar