Stenting Malignant Jaundice for Quality of Life

Indiana University

Status: Completed

Conditions: Bile Duct Neoplasms Malignant

Treatments: Procedure: ERCP with 11.5 French biliary plastic stent; Procedure: ERCP with 10 French biliary plastic stent placement

Study type: Interventional

Funder types: Other

Identifiers

NCT01459965

9307-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 164 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

10 French Stent

Active Comparator group

Description:

10 French biliary plastic stent

Treatment:

Procedure: ERCP with 10 French biliary plastic stent placement

11.5 French stent

Active Comparator group

Description:

11.5 French biliary plastic stent

Treatment:

Procedure: ERCP with 11.5 French biliary plastic stent