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Completed

NCT Number: NCT01459965

Stenting Malignant Jaundice for Quality of Life

Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.

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Key information

About this study

Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.

Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.

Exclusion criteria

  • Had previously undergone biliary stenting
  • Surgery was planned
  • A guidewire could not be passed through the stricture
  • Suspected survival of < 3 months
  • Impending duodenal obstruction

Treatment and study plan

ERCP with 10 French biliary plastic stent placement

Procedure

Stent placement of a 10 French biliary plastic stent

ERCP with 11.5 French biliary plastic stent

Procedure

biliary plastic stent placement

Primary outcomes

  1. Documented change in Quality Of Life

    Time frame: 180 days after stent insertion

    Documented change in QOL over the first month and over six months after successful biliary drainage compared with that before the procedure. The FACT-G questionnaire administered at baseline, at 1 month after stent insertion and at 180 days after stent insertion was used to assess this outcome. Change from baseline was analyzed at each of these time points separately.

Secondary outcomes

  1. Documented change in symptoms and concerns specific for patients with MBDO

    Time frame: 180 days after stent placement

    An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • American College of Gastroenterology
  • American Society for Gastrointestinal Endoscopy

Registry information

Official study title

Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life

Important dates

Study start
1993
Primary completion
2004
Study completion
2004
First posted
Oct 26, 2011
Registry last updated
Oct 26, 2011

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.

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