Stenting Malignant Jaundice for Quality of Life
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bile Duct Neoplasms Malignant |
Procedure: ERCP with 10 French biliary plastic stent placement Procedure: ERCP with 11.5 French biliary plastic stent |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.
| Enrollment: | 164 |
| Study Start Date: | July 1993 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT01459965 History of Changes |
| Other Study ID Numbers: | 9307-04 |
| Study First Received: | October 21, 2011 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Jaundice Biliary stents Palliation Quality of Life Endoscopic Retrograde Cholangiography |
Additional relevant MeSH terms:
|
Bile Duct Neoplasms Neoplasms Biliary Tract Neoplasms Digestive System Neoplasms |
Neoplasms by Site Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013