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

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Bile Duct Neoplasms Malignant

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Documented change in Quality Of Life

Outcome Description:

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.

Outcome Time Frame:

180 days after stent insertion

Safety Issue:


Principal Investigator

Stuart Sherman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

July 1993

Completion Date:

November 2004

Related Keywords:

  • Bile Duct Neoplasms Malignant
  • Jaundice
  • Biliary stents
  • Palliation
  • Quality of Life
  • Endoscopic Retrograde Cholangiography
  • Bile Duct Neoplasms
  • Neoplasms