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Completed

NCT Number: NCT01047332

A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.

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Key information

Conditions

Inoperable Tumors of the Bile Duct

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).

Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age.
  • Malignant bile duct stricture.
  • Increased bilirubin.
  • Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
  • Not an operative candidate.

Exclusion criteria

  • Unable to obtain consent.
  • Unable to tolerate procedure.
  • Suspected benign bile duct stricture.
  • Candidate for potentially curative surgical intervention.
  • Previous metallic biliary stent.
  • Previous bile duct surgery.

Treatment and study plan

Partially Covered Wallstent

Device

Partially covered wallstent

Uncovered Wallstent

Device

Uncovered wallstent

Primary outcomes

  1. Time to Recurrent Biliary Obstruction

    Time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

    Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.

Secondary outcomes

  1. Patient Survival

    Time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

    Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From time of stent placement to participant death or lost to follow-up (up to 1302 days)

    Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.

  3. Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism

    Time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

    Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

Acronym: Wallstent

Important dates

Study start
2002
Primary completion
2008
Study completion
2009
First posted
Jan 12, 2010
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.