Covered Metal Stents for Treatment of Post-liver Transplant Biliary Strictures - Full Text View

Purpose

The current standard of care for post-liver transplant bile duct strictures involves serial 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 pilot 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 over a shorter time.

Condition	Intervention
Anastomotic Biliary Stricture	Device: fully covered Wallflex biliary stent Procedure: Plastic stent

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

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Early stricture resolution [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary end point is early stricture resolution, defined as fluoroscopic resolution after six months of stent therapy in each group. This short term outcome measure will translate into long term cost savings by reducing the time and number of procedures required to treat a bile duct stricture.

Secondary Outcome Measures:

Long term efficacy and complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Efficacy will be measured by technical success, short term clinical success and long term clinical success as defined under secondary outcomes within the protocol. Procedure-related complications will be defined as post-ERCP pancreatitis, bowel perforation, GI hemorrhage related to the ERCP, stent migration and early stent occlusion. Long term complications are defined as stent-associated strictures noted on cholangiography at stent removal and stricture recurrence during the post-stenting follow-up period (one year).
Cost [ Time Frame: 2 years ] [ Designated as safety issue: No ]
We plan to track all hospital, facility and physician charges accrued during the study period for patients enrolled in the pilot study. We plan to compare total charges as well as those charges directly associated with stricture treatment.
Stent-associated changes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Physicians who are blinded to the patient's identity and study group will evaluate completion cholangiograms for irregularities along the duct wall. Inter-observer variability will be calculated in an effort to validate this approach for a larger clinical trial to follow.
Patient satisfaction, quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Patients will be asked to complete a patient satisfaction instrument (ASGE modified GHAA-9) at the time of final stent removal and quality of life instrument (SF-36 v2) at enrollment, final stent removal and study completion (one year after all stents have been removed).

Estimated Enrollment:	30
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Covered metallic stent Among patients randomized to the 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. If the proximal or distal bile duct measures 6-8 mm in diameter, the endoscopist will use an 8 mm diameter cSEMS. All other strictures will be treated using a cSEMS with a diameter of 10 mm. The length of cSEMS (fully covered Wallflex™, Boston Scientific, Natick, MA) will be left to the discretion of the treating endoscopist. The diameter and length of stent will be recorded, and a flow diagram of anticipated clinical and endoscopic follow-up is attached (figure 2).	Device: fully covered Wallflex biliary stent fully covered Wallflex biliary stent, Boston Scientific, Natick, MA Other Names: fully covered metallic stent covered metallic stent self-expandable metallic stent
Active Comparator: 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 (every 3 months), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).	Procedure: Plastic stent Polyethylene biliary stents will be used for treatment. This represents the current standard of care.

Arms

Assigned Interventions

Experimental: Covered metallic stent

Among patients randomized to the 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. If the proximal or distal bile duct measures 6-8 mm in diameter, the endoscopist will use an 8 mm diameter cSEMS. All other strictures will be treated using a cSEMS with a diameter of 10 mm. The length of cSEMS (fully covered Wallflex™, Boston Scientific, Natick, MA) will be left to the discretion of the treating endoscopist. The diameter and length of stent will be recorded, and a flow diagram of anticipated clinical and endoscopic follow-up is attached (figure 2).

Device: fully covered Wallflex biliary stent

fully covered Wallflex biliary stent, Boston Scientific, Natick, MA

Other Names:

fully covered metallic stent
covered metallic stent
self-expandable metallic stent

Active Comparator: 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 (every 3 months), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).

Procedure: Plastic stent

Polyethylene biliary stents will be used for treatment. This represents the current standard of care.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Known or suspected benign, Bismuth type I (defined as a common bile duct or common hepatic duct stricture whose proximal margin is ≥ 2 cm from the hepatic bifurcation) bile duct stricture secondary to a post-liver transplant biliary anastomosis, and
Objective signs or symptoms related to the biliary stricture, including laboratory evidence of cholestasis, jaundice, or cholangitis.

Exclusion criteria:

Suspected malignant etiology for the stricture, or
Recent (defined as < 1 year) endoscopic therapy to the same stricture, except for a single PS within 30 days of liver transplant, or
Greatest diameter of proximal common hepatic duct < 6 mm (since the smallest diameter cSEMS is 8 mm)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432808

Locations

United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Gregory A Cote, MD, MS

Indiana University School of Medicine

More Information

No publications provided

Responsible Party:	Gregory A. Cote, Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier:	NCT01432808 History of Changes
Other Study ID Numbers:	10746679, 1R21DK090708-01A1
Study First Received:	September 2, 2011
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

bile duct stricture
liver transplant
bile duct anastomosis
post-liver transplant

Additional relevant MeSH terms:

Cholestasis
Constriction, Pathologic
Bile Duct Diseases

Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013