Clinical trial NCT01459965: Stenting Malignant Jaundice for Quality of Life
Official title: Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Neoplasms Malignant
Keywords: Jaundice
Biliary stents
Palliation
Quality of Life
Endoscopic Retrograde Cholangiography
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: American College of Gastroenterology
First posted: 2011-10-26
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Documented change in Quality Of Life
timeFrame: 180 days after stent insertion
Secondary outcomes:
measure: Documented change in symptoms and concerns specific for patients with MBDO
timeFrame: 180 days after stent placement
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University School of Medicine
name: Stuart Sherman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana Univesity Medical Center
name: Glen A Lehman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rockford GE Associates
name: James Frankes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rockford GE Associates
name: John Johanson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MaineHealth
name: Tahir Qaseem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MaineHealth
name: Douglas Howell, MD
role: PRINCIPAL_INVESTIGATOR
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