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

Benign Biliary Strictures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238900
• Other study ID #: Benign Biliary Strictures
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: August 31, 2015
• Start date: May 2009
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Biliary Strictures
• Cholestasis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
United States	Shands at UF endoscopy center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of Endoscopic Treatments Per Patient	The average number of ERCPs performed per patient required for resolution of benign strictures.	At time of procedure	No
Secondary	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	No
Secondary	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	Yes