SpyGlass AMEA Registry

NCT02281019 | Completed

• 1 other identifier: 90947376
• Study Type: observational
• Target: 526
• Locations: 10 countries
• Sites: 20

Brief Summary

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.

Conditions

Biliary Stricture; Biliary Obstruction Due to Common Bile Duct Stone; Periampullary Tumor; Hemobilia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure

  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.

  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

Study Arms (3)

Indeterminate strictures or undefined filling defects

Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); Device: SpyGlass DVS and SpyGlass Digital Simple (DS)

Biliary stone cases

Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); Device: SpyGlass DVS and SpyGlass Digital Simple (DS)

Other indications

Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); Device: SpyGlass DVS and SpyGlass Digital Simple (DS)

Interventions

ERCP (Endoscopic Retrograde Cholangiopancreatography) PROCEDURE

ERCP procedure will be performed to visualize bile ducts.

Biliary stone cases; Indeterminate strictures or undefined filling defects; Other indications

SpyGlass DVS and SpyGlass Digital Simple (DS) DEVICE

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; Indeterminate strictures or undefined filling defects; Other indications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (20)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Royal Prince Alfred Hospital

Newtown, Australia

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Apollo Gleneagles Hospitals Kolkata

Kolkata, West Bengal, 70054, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, India

Location

Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences

Gūrgaon, India

Location

Asian Institute of Gastroenterology

Hyderabad, India

Location

Baldota Institute of Digestive Sciences

Pārel, 400012, India

Location

Teikyo University Mizonokuchi Hospital

Kawasaki, Japan

Location

Kinki University School of Medicine

Ōsaka-sayama, Japan

Location

Tokyo Medical University

Tokyo, Japan

Location

Civil Hospital- Karachi

Karachi, Pakistan

Location

King Khalid University Hospital

Riyadh, Saudi Arabia

Location

Changi General Hospital Pte Ltd.

Singapore, Singapore

Location

Netcare Unitas Hospital

Centurion, South Africa

Location

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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.

  PMID: 31250408 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue acquisition in the bile ducts

MeSH Terms

Conditions

Hemobilia

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 3, 2014
• Study Start: November 15, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 18, 2016
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

IN (5); PA (1); JP (3); SG (1); HK (1); KR (3); ZA (1); AU (3); SA (1); TH (1)