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Trial record 1 of 1 for:
"Hemobilia"
SpyGlass AMEA Registry
This study is ongoing, but not recruiting participants.
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02281019
First received: October 9, 2014
Last updated: May 26, 2016
Last verified: January 2016
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Purpose
The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.
| Condition | Intervention |
|---|---|
| Biliary Stricture Biliary Obstruction Due to Common Bile Duct Stone Periampullary Tumor Hemobilia | Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography) Device: SpyGlass DVS and SpyGlass DS |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region |
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Procedural success for indeterminate strictures or undefined filling defects [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]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
- Procedural success for biliary stone cases [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]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.
- Procedural success for other indications [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]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.
Secondary Outcome Measures:
- Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure [ Time Frame: Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit ]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.
- Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Procedure to 6 months ]
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.
- For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Procedure - the average expected duration of the procedure is 1.5 hours ]
Biospecimen Retention: Samples Without DNA
Tissue acquisition in the bile ducts
| Enrollment: | 526 |
| Study Start Date: | November 2014 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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 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 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 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02281019
Please refer to this study by its ClinicalTrials.gov identifier: NCT02281019
Locations
| Australia | |
| Royal Adelaide Hospital | |
| Adelaide, Australia | |
| Royal Prince Alfred Hospital | |
| Newtown, Australia | |
| Royal Brisbane and Women's Hospital | |
| Queensland, Australia | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Shatin, Hong Kong | |
| India | |
| Postgraduate Institute of Medical Education & Research | |
| Chandigarh, India | |
| Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences | |
| Gurgaon, India | |
| Asian Institute of Gastroenterology | |
| Hyderabad, India | |
| Baldota Institute of Digestive Sciences | |
| Parel, India, 400012 | |
| Apollo Gleneagles Hospitals Kolkata | |
| West Bengal, India | |
| Japan | |
| Teikyo University Mizonokuchi Hospital | |
| Kawasaki, Japan | |
| Kinki University School of Medicine | |
| Osaka-sayama, Japan | |
| Tokyo Medical University | |
| Tokyo, Japan | |
| Korea, Republic of | |
| Soon Chun Hyang University Bucheon Hospital | |
| Bucheon, Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
| Pakistan | |
| Civil Hospital- Karachi | |
| Karachi, Pakistan | |
| Saudi Arabia | |
| King Khalid University Hospital | |
| Riyadh, Saudi Arabia | |
| Singapore | |
| Changi General Hospital Pte Ltd. | |
| Singapore, Singapore | |
| South Africa | |
| Netcare Unitas Hospital | |
| Centurion, South Africa | |
| Thailand | |
| King Chulalongkorn Memorial Hospital | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
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 |
More Information
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT02281019 History of Changes |
| Other Study ID Numbers: |
90947376 |
| Study First Received: | October 9, 2014 |
| Last Updated: | May 26, 2016 |
Additional relevant MeSH terms:
|
Hemobilia Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on July 14, 2017