Stenting Malignant Jaundice for Quality of Life

Not Applicable

Completed

• Conditions: Bile Duct Neoplasms Malignant
• Interventions: Procedure: ERCP with 10 French biliary plastic stent placement; Procedure: ERCP with 11.5 French biliary plastic stent

• Registration Number: NCT01459965
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 1993-07
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2011-10
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-25
• Last Update Submitted: 2011-10-25
• Study First Posted: 2011-10-26
• Last Update Posted: 2011-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 French Stent	ERCP with 10 French biliary plastic stent placement	10 French biliary plastic stent
11.5 French stent	ERCP with 11.5 French biliary plastic stent	11.5 French biliary plastic stent

Primary Outcome Measures

Name	Time	Method
Documented change in Quality Of Life	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 Outcome Measures

Name	Time	Method
Documented change in symptoms and concerns specific for patients with MBDO	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.