Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures

Common Bile Duct Stricture Clinical Trial

Official title:

Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01221311
• Other study ID #: G100118
• Secondary ID: R21DK090708
• Status: Active, not recruiting
• Phase: N/A
• First received: October 8, 2010
• Last updated: March 14, 2016
• Start date: January 2011
• Est. completion date: October 2016

Study information

• Verified date: March 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.

Description:

Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).

Other known NCT identifiers

• NCT01432808

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bismuth Type I benign bile duct stricture

• Objective signs/symptoms related to the stricture

Exclusion Criteria:

• Suspected malignant etiology for the stricture

• Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early (< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ERCP while evaluating for malignancy

• Bismuth Type II-IV stricture

• Proximal common hepatic duct diameter < 6 mm

• Intact gallbladder, except in cases where a stent can be deployed > 1cm below the cystic duct insertion

• Age < 18 years, pregnancy, incarceration, inability to provide informed consent

• Karnofsky score = 40

• Inability to pass a guidewire proximal to the stricture

• Stricture > 8cm in length

• Life expectancy < 1 year

• Concomitant nonanastomotic biliary strictures or biliary casts

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Bile Duct Stricture
• Constriction, Pathologic

Intervention

Device:
• Fully covered Metallic Stent
Covered Wallflex Biliary (TM)
• Plastic Stent
Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing ERCPs, until the stricture has been obliterated using clinical and fluoroscopic criteria.

Locations

Country	Name	City	State
United Kingdom	Royal Wolverhampton NHS Trust	Wolverhampton
United States	University of Michigan	Ann Arbor	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Digestive Health Associates of Texas	Dallas	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University in St. Louis	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	American Society for Gastrointestinal Endoscopy, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Clinical Success	Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.	Post-stent removal (up to one year after enrollment)	No
Secondary	Technical success	Technical success will be defined as the completion of the initial and each follow-up ERCP, including stent deployment and removal. Cases where stents cannot be deployed or removed via endoscopy will be considered technical failures. We will compare technical success rates in each group.	After each procedure, procedures are performed every 3 months for up to one year	Yes
Secondary	Late clinical success	Late clinical success will be defined as fluoroscopic resolution at the time of final stent(s) withdrawal as well as the absence of objective findings of stricture recurrence during the one year, post-stenting follow-up period.	Up to two years after enrollment	No
Secondary	Cost analysis	For patients at the coordinating center, costs will be measured from multiple sources. The primary source of direct costs associated with cSEMS and PS is from the billing department of the local health system, which has agreed to provide us with the paid charges for our enrolled patients for two years from the first ERCP. We will include all care directly related to the stricture, including inpatient hospitalizations for the management of complications.	One year post-stent removal (up to two years after enrollment)	No
Secondary	Complication rates	Complication rates will be assessed by the number of procedure-related complications, including post-ERCP pancreatitis, bowel perforation, gastrointestinal bleeding, stent-associated stricture/change (see below) and stent migration. In addition, the endoscopic removability of the cSEMS will be recorded. Complications will be classified as major or minor. A major complication will be defined as any procedure-related complication that requires procedural intervention or hospitalization for > 5 days. All other complications will be classified as minor.	Throughout study period (up to two years after enrollment)	Yes
Secondary	Stent-associated ductal changes	Physicians with extensive experience in ERCP will review completion cholangiograms that are obtained at the time of final stent withdrawal.	Post-stenting (up to one year after enrollment)	Yes