Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation
The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.
1 other identifier
interventional
4
1 country
1
Brief Summary
Primary Objective: To document state-of- the-art multi-modality management of occluded biliary SEMS aiming to minimize number of reinterventions while providing symptom relief without procedure-related serious adverse events. NOTE: This study will be hypothesis-generating for an anticipated randomized controlled study (RCT) to compare outcomes of placement of a plastic stent inside the occluded SEMS to outcomes of the proposed multi-modality approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedApril 28, 2017
April 1, 2017
2 years
April 25, 2017
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful restoration of bile duct drainage
Successful restoration of bile duct drainage with biliary obstructive symptom and cholangitis relief as applicable, without procedure related SAE'S, from procedure through 30 days followup.
1 month
Secondary Outcomes (1)
Resolution of cholangitis
1 week and 1 month
Study Arms (2)
Sludge group
ACTIVE COMPARATORIf Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP.
Ingrowth / Overgrowth
ACTIVE COMPARATORIf Single operator cholangioscopy reveals tumour ingrowth or overgrowth then to evaluate the role of biliary RFA for occluded stent due to tumour ingrowth or overgrowth
Interventions
Single operator cholangioscopy will be done to acess the cause of occluded SEMS, if tumour ingrowth or overgrowth seen then endoscopic biliary RFA will be done
Eligibility Criteria
You may qualify if:
- \. Age 18 or older 2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study 3. Recurrent biliary obstructive symptoms after biliary SEMS placement 4. Biliary SEMS occlusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohan Ramchandani, MD DM
Asian Institute of Gastroenterology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Gastroenterologist
Study Record Dates
First Submitted
April 25, 2017
First Posted
April 28, 2017
Study Start
June 1, 2016
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
April 28, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share