Clinical trial NCT01221311: Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
Official title: Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Stricture
Keywords: stenosis
bile duct
chronic pancreatitis
postoperative
post-liver transplant
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-10-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Early Clinical Success
timeFrame: Post-stent removal (up to one year after enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Digestive Health Associates of Texas
state: Texas
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton NHS Trust
Study officials:
affiliation: Medical University of South Carolina
name: Gregory A Cote, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619.