Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation
NCT ID: NCT03133026
Last Updated: 2017-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4 participants
INTERVENTIONAL
2016-06-30
2018-07-31
Brief Summary
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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.
Detailed Description
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Prospective, multi-center, single arm, post market, observational study
Two groups:
* Sludge group: SEMS occluded due to sludge/stones in SEMS
* Ingrowth/overgrowth group: SEMS occluded due to malignant tumor ingrowth or benign hyperplastic tissue overgrowth
Primary Endpoint:
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 of follow-up.
Secondary Endpoints:
1. Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure
2. Resolution of cholangitis where applicable
3. Technical success of procedure performed for restoration of bile duct drainage, overall and stratified by treatment group Sludge group: Ability to restore stent patency by cleaning the stent content followed by cholangiographically or cholangioscopically confirmed restored stent patency Ingrowth / overgrowth group: Ability to perform biliary radio frequency ablation (RFA) followed by cholangiographically or cholangioscopically confirmed restored stent patency
4. Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline
5. Improvement of Laboratory Liver Function Tests (LFT) at 1 week and 1 month post procedure compared to Baseline
6. Biliary Reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion
7. Impact of cholangioscopy on current standard of care, which is to place a stent inside the occluded SEMS by
* Avoiding placement of a second stent (plastic or metal)
* Avoiding a repeat ERCP
* Reducing associated cost
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Sludge group
If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP.
Single operator cholangioscopy, Endoscopic biliary RFA
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
Ingrowth / Overgrowth
If 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
Single operator cholangioscopy, Endoscopic biliary RFA
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
Interventions
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Single operator cholangioscopy, Endoscopic biliary RFA
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Consultant Gastroenterologist
Principal Investigators
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Mohan Ramchandani, MD DM
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Locations
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Asian Institute of Gastroenterology
Hyderabad, Telangana, India
Countries
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Central Contacts
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Facility Contacts
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Mohan Ramchandani, MD DM
Role: primary
Other Identifiers
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AIG-001
Identifier Type: -
Identifier Source: org_study_id