Stenting Malignant Jaundice for Quality of Life
|Bile Duct Neoplasms Malignant||Procedure: ERCP with 10 French biliary plastic stent placement Procedure: ERCP with 11.5 French biliary plastic stent|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life|
- 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.
- 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.
|Study Start Date:||July 1993|
|Study Completion Date:||November 2004|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Active Comparator: 10 French Stent
10 French biliary plastic stent
Procedure: ERCP with 10 French biliary plastic stent placement
Stent placement of a 10 French biliary plastic stent
Active Comparator: 11.5 French stent
11.5 French biliary plastic stent
Procedure: ERCP with 11.5 French biliary plastic stent
biliary plastic stent placement
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459965
|Principal Investigator:||Stuart Sherman, MD||Indiana University School of Medicine|
|Principal Investigator:||Glen A Lehman, MD||Indiana Univesity Medical Center|
|Principal Investigator:||James Frankes, MD||Rockford GE Associates|
|Principal Investigator:||John Johanson, MD||Rockford GE Associates|
|Principal Investigator:||Tahir Qaseem, MD||Maine Medical Center|
|Principal Investigator:||Douglas Howell, MD||Maine Medical Center|