SpyGlass AMEA Registry

Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

Study Overview

• Status: Completed
• Conditions: Biliary Stricture; Periampullary Tumor; Biliary Obstruction Due to Common Bile Duct Stone; Hemobilia
• Intervention / Treatment: Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); Device: SpyGlass DVS and SpyGlass Digital Simple (DS)

• Study Type: Observational
• Enrollment (Actual): 526

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Newtown, Australia
    • Royal Prince Alfred Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital
• India
  • Chandigarh, India
    • Postgraduate Institute of Medical Education & Research
  • Gurgaon, India
    • Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences
  • Hyderabad, India
    • Asian Institute of Gastroenterology
  • Parel, India, 400012
    • Baldota Institute of Digestive Sciences
  • West Bengal
    • Kolkata, West Bengal, India, 70054
      • Apollo Gleneagles Hospitals Kolkata
• Japan
  • Kawasaki, Japan
    • Teikyo University Mizonokuchi Hospital
  • Osaka-sayama, Japan
    • Kinki University School of Medicine
  • Tokyo, Japan
    • Tokyo Medical University
• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Bucheon Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
• Pakistan
  • Karachi, Pakistan
    • Civil Hospital- Karachi
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Khalid University Hospital
• Singapore
  • Singapore, Singapore
    • Changi General Hospital Pte Ltd.
• South Africa
  • Centurion, South Africa
    • Netcare Unitas Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients seen at an investigational site during the enrollment period

• Presenting with an indication for cholangioscopy, or
• Presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure.

Description

Inclusion Criteria:

• Age 18 or older.
• Willing and able to provide written informed consent to participate in the study.
• Willing and able to comply with the study procedures.
• Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.

Exclusion Criteria:

• Endoscopic techniques are contraindicated.
• ERCP is contraindicated
• A medical condition that warrants the use of the device outside of the indication for use.
• Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Indeterminate strictures or undefined filling defects	Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); ERCP procedure will be performed to visualize bile ducts.; Device: SpyGlass DVS and SpyGlass Digital Simple (DS); Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
Biliary stone cases	Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); ERCP procedure will be performed to visualize bile ducts.; Device: SpyGlass DVS and SpyGlass Digital Simple (DS); Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
Other indications	Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); ERCP procedure will be performed to visualize bile ducts.; Device: SpyGlass DVS and SpyGlass Digital Simple (DS); Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success for indeterminate strictures or undefined filling defects	For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology	Procedure - the average expected duration of the procedure is 1.5 hours
Procedural success for biliary stone cases	For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.	Procedure - the average expected duration of the procedure is 1.5 hours
Procedural success for other indications	For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.	Procedure - the average expected duration of the procedure is 1.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure	Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit.	Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit
Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP		Procedure - the average expected duration of the procedure is 1.5 hours
Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.		Procedure - the average expected duration of the procedure is 1.5 hours
For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.	Assessment Detail: Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported. Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus.	Procedure to 6 months
For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.		Procedure - the average expected duration of the procedure is 1.5 hours
For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.		Procedure - the average expected duration of the procedure is 1.5 hours
For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.		Procedure - the average expected duration of the procedure is 1.5 hours

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Benedict Devereaux, Royal Brisbane and Women's Hospital; Principal Investigator: James Lau, Prince of Wales Hospital; Principal Investigator: Randhir Sud, Institute of Digestive & Hepatobiliary Sciences; Principal Investigator: Saad Niaz, Civil Hospital- Karachi; Principal Investigator: Abdulrahman Aljebreen, King Khalid University Hospital; Principal Investigator: Ang Tiing Leong, Changi General Hospital Pte Ltd.; Principal Investigator: Jorg Reichenberger, Netcare Unitas Hospital; Principal Investigator: Jong Moon, Soon Chun Hyang University; Principal Investigator: Rungsun Rerknimitr, King Chulalongkorn Memorial Hospital; Principal Investigator: Ichiro Yasuda, Teikyo University Mizonokuchi Hospital; Principal Investigator: Arthur J. Kaffes, Royal Prince Alfred Hospital, Sydney, Australia; Principal Investigator: Nam Q. Nguyen, Royal Adelaide Hospital; Principal Investigator: Amit Maydeo, Baldota Institute of Digestive Sciences; Principal Investigator: Mohan Ramchandani, Asian Institute of Gastroenterology; Principal Investigator: Mahesh Goenka, Apollo Gleneagles Hospital; Principal Investigator: Professor R. Kochhar, Postgraduate Institute of Medical Education & Research; Principal Investigator: Takao Itoi, Tokyo Medical University; Principal Investigator: Masayuki Kitano, Kinki University School of Medicine; Principal Investigator: Jong K. Lee, Samsung Medical Center; Principal Investigator: Dongwan Seo, Asan Medical Center

Publications and helpful links

General Publications

• Maydeo AP, Rerknimitr R, Lau JY, Aljebreen A, Niaz SK, Itoi T, Ang TL, Reichenberger J, Seo DW, Ramchandani MK, Devereaux BM, Lee JK, Goenka MK, Sud R, Nguyen NQ, Kochhar R, Peetermans J, Goswamy PG, Rousseau M, Bhandari SP, Angsuwatcharakon P, Tang RSY, Teoh AYB, Almadi M, Lee YN, Moon JH; SpyGlass AMEA Registry Group. 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 Oct;51(10):922-929. doi: 10.1055/a-0942-9336. Epub 2019 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 18, 2016

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hemobilia
• Other Study ID Numbers: 90947376