Clinical trial NCT02281019: SpyGlass AMEA Registry
Official title: Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stricture
Biliary Obstruction Due to Common Bile Duct Stone
Periampullary Tumor
Hemobilia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Procedural success for indeterminate strictures or undefined filling defects
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
measure: Procedural success for biliary stone cases
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
measure: Procedural success for other indications
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
Secondary outcomes:
measure: Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure
timeFrame: Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit
measure: Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
measure: Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
measure: For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.
timeFrame: Procedure to 6 months
measure: For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
measure: For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
measure: For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.
timeFrame: Procedure - the average expected duration of the procedure is 1.5 hours
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Newtown
country: Australia
facility: Royal Prince Alfred Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Kolkata
state: West Bengal
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
city: Gurgaon
country: India
facility: Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Parel
country: India
facility: Baldota Institute of Digestive Sciences
city: Kawasaki
country: Japan
facility: Teikyo University Mizonokuchi Hospital
city: Osaka-sayama
country: Japan
facility: Kinki University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Karachi
country: Pakistan
facility: Civil Hospital- Karachi
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital Pte Ltd.
city: Centurion
country: South Africa
facility: Netcare Unitas Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Royal Brisbane and Women's Hospital
name: Benedict Devereaux
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: James Lau
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Digestive & Hepatobiliary Sciences
name: Randhir Sud
role: PRINCIPAL_INVESTIGATOR
affiliation: Civil Hospital Karachi
name: Saad Niaz
role: PRINCIPAL_INVESTIGATOR
affiliation: King Khalid University Hospital
name: Abdulrahman Aljebreen
role: PRINCIPAL_INVESTIGATOR
affiliation: Changi General Hospital Pte Ltd.
name: Ang Tiing Leong
role: PRINCIPAL_INVESTIGATOR
affiliation: Netcare Unitas Hospital
name: Jorg Reichenberger
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University
name: Jong Moon
role: PRINCIPAL_INVESTIGATOR
affiliation: King Chulalongkorn Memorial Hospital
name: Rungsun Rerknimitr
role: PRINCIPAL_INVESTIGATOR
affiliation: Teikyo University Mizonokuchi Hospital
name: Ichiro Yasuda
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Arthur J. Kaffes
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Adelaide Hospital
name: Nam Q. Nguyen
role: PRINCIPAL_INVESTIGATOR
affiliation: Baldota Institute of Digestive Sciences
name: Amit Maydeo
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Institute of Gastroenterology
name: Mohan Ramchandani
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Gleneagles Hospital
name: Mahesh Goenka
role: PRINCIPAL_INVESTIGATOR
affiliation: Postgraduate Institute of Medical Education & Research
name: Professor R. Kochhar
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo Medical University
name: Takao Itoi
role: PRINCIPAL_INVESTIGATOR
affiliation: Kinki University School of Medicine
name: Masayuki Kitano
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jong K. Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Dongwan Seo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.