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

University of Florida23 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Benign Biliary Strictures

Interventions

Endoscopic Retrograde Cholangiopancreatography (ERCP)PROCEDURE

Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shands at UF endoscopy center

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Short Term Success Rate in the Resolution of Biliary Strictures

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.

Time frame: 6 months

Long-term Success Rate in Resolution of Biliary Strictures

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.

Time frame: at least 12 months after stent removal

Secondary Outcomes

Number of Endoscopic Treatments Per Patient

The average number of ERCPs performed per patient required for resolution of benign strictures.

Time frame: At time of procedure

Ease of Stent Removal

The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).

Time frame: at time of procedure

Frequency and Severity of Adverse Events (Including Stent Migration)

Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria

Time frame: up to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.