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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Common Bile Duct Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fully covered Metallic Stent

Intervention Type DEVICE

Covered Wallflex Biliary (TM)

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 multiple (as many as technically feasible) 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).

Group Type ACTIVE_COMPARATOR

Plastic Stent

Intervention Type DEVICE

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.

Interventions

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Fully covered Metallic Stent

Covered Wallflex Biliary (TM)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Polyethylene Stent

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No