Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures

Completed

• Conditions: Benign Biliary Strictures
• Interventions: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

• Registration Number: NCT01238900
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.

Detailed Description

In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2015-06-29
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Results First Posted: 2015-10-02
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Subject is 18 years or older
2. Subject has benign biliary stricture
3. Subject must be able to give informed consent

Exclusion Criteria

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
2. The subject is unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
benign biliary strictures	Endoscopic Retrograde Cholangiopancreatography (ERCP)	All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures

Primary Outcome Measures

Name	Time	Method
Short Term Success Rate in the Resolution of Biliary Strictures	6 months	Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.
Long-term Success Rate in Resolution of Biliary Strictures	at least 12 months after stent removal	Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.

Secondary Outcome Measures

Name	Time	Method
Ease of Stent Removal	at time of procedure	The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).
Frequency and Severity of Adverse Events (Including Stent Migration)	up to 12 months	Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria
Number of Endoscopic Treatments Per Patient	At time of procedure	The average number of ERCPs performed per patient required for resolution of benign strictures.

Trial Locations

Locations (1)

Shands at UF endoscopy center; 🇺🇸 Gainesville, Florida, United States