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Protocol for increasing number of stents across the anastomosis for Anastomotic Stenosis
N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after final study ercp with stent removal
Awards & highlights
Summary
This trial will help determine the best way to treat patients who develop biliary strictures after liver transplantation.
Eligible Conditions
- Anastomotic Stenosis
- Biliary Strictures
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after final study ercp with stent removal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after final study ercp with stent removal
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anastomotic biliary stricture resolution
Secondary outcome measures
Adverse Events
Fluoroscopy Parameters
Sustained resolution of anastomotic stricture for 12 months
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sequential stent additionExperimental Treatment1 Intervention
ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation.
Group II: Incremental Dilation & Stent ExchangeActive Control1 Intervention
ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,839 Total Patients Enrolled
University of RochesterOTHER
847 Previous Clinical Trials
535,297 Total Patients Enrolled
University of BarcelonaOTHER
143 Previous Clinical Trials
59,762 Total Patients Enrolled
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