Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
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.
Benign Bile Duct Strictures
Device: Fully covered Metallic Stent
Device: Plastic Stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures|
- Late Clinical Success [ Time Frame: Up to two years after enrollment ] [ Designated as safety issue: No ]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.
- Technical success [ Time Frame: After each procedure, procedures are performed every 3 months for up to one year ] [ Designated as safety issue: Yes ]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.
- Early clinical success [ Time Frame: Post-stent removal (up to one year after enrollment) ] [ Designated as safety issue: No ]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.
- Cost analysis [ Time Frame: One year post-stent removal (up to two years after enrollment) ] [ Designated as safety issue: No ]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.
- Complication rates [ Time Frame: Throughout study period (up to two years after enrollment) ] [ Designated as safety issue: Yes ]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.
- Stent-associated ductal changes [ Time Frame: Post-stenting (up to one year after enrollment) ] [ Designated as safety issue: Yes ]Physicians with extensive experience in ERCP will review completion cholangiograms that are obtained at the time of final stent withdrawal.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Fully Covered Metallic Stent
Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Device: Fully covered Metallic Stent
Covered Wallflex Biliary (TM)
Active Comparator: Plastic Stent
Patients randomized to the plastic stent (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 endoscopic retrograde cholangiopancreatography (ERCP)), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).
Device: Plastic Stent
Patients randomized to the PS group will be treated using a standard algorithm (figure 2). 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 (details below).
Other Name: Polyethylene Stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221311
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States|
|United States, Missouri|
|Washington University in St. Louis|
|St. Louis, Missouri, United States, 63108|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Digestive Health Associates of Texas|
|Dallas, Texas, United States|
|Royal Wolverhampton NHS Trust|
|Wolverhampton, United Kingdom|
|Principal Investigator:||Gregory A Cote, MD, MS||Medical University of South Carolina|