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

Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures

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.

Study Overview

• Status: Completed
• Conditions: Benign Biliary Strictures
• Intervention / Treatment: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Shands at UF endoscopy center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have a medical indication for endoscopic therapy of benign biliary stictures and are referred for the procedure as part of their standard medical care will be considered for the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
benign biliary strictures; All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures	Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP); Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at least 12 months after stent removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Endoscopic Treatments Per Patient	The average number of ERCPs performed per patient required for resolution of benign strictures.	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).	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	up to 12 months

Collaborators and Investigators

• Sponsor: University of Florida

Publications and helpful links

General Publications

• Wagh MS, Chavalitdhamrong D, Moezardalan K, Chauhan SS, Gupte AR, Nosler MJ, Forsmark CE, Draganov PV. Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent. Diagn Ther Endosc. 2013;2013:183513. doi: 10.1155/2013/183513. Epub 2013 May 11.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: Benign Biliary Strictures