Stenting Malignant Jaundice for Quality of Life
Primary Purpose
Bile Duct Neoplasms Malignant
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ERCP with 10 French biliary plastic stent placement
ERCP with 11.5 French biliary plastic stent
Sponsored by
About this trial
This is an interventional supportive care trial for Bile Duct Neoplasms Malignant focused on measuring Jaundice, Biliary stents, Palliation, Quality of Life, Endoscopic Retrograde Cholangiography
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
10 French Stent
11.5 French stent
Arm Description
10 French biliary plastic stent
11.5 French biliary plastic stent
Outcomes
Primary Outcome Measures
Documented change in Quality Of Life
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
Documented change in symptoms and concerns specific for patients with MBDO
An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.
Full Information
NCT ID
NCT01459965
First Posted
October 21, 2011
Last Updated
October 25, 2011
Sponsor
Indiana University
Collaborators
American Society for Gastrointestinal Endoscopy, American College of Gastroenterology
1. Study Identification
Unique Protocol Identification Number
NCT01459965
Brief Title
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
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 1993 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
American Society for Gastrointestinal Endoscopy, American College of Gastroenterology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Neoplasms Malignant
Keywords
Jaundice, Biliary stents, Palliation, Quality of Life, Endoscopic Retrograde Cholangiography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 French Stent
Arm Type
Active Comparator
Arm Description
10 French biliary plastic stent
Arm Title
11.5 French stent
Arm Type
Active Comparator
Arm Description
11.5 French biliary plastic stent
Intervention Type
Procedure
Intervention Name(s)
ERCP with 10 French biliary plastic stent placement
Intervention Description
Stent placement of a 10 French biliary plastic stent
Intervention Type
Procedure
Intervention Name(s)
ERCP with 11.5 French biliary plastic stent
Intervention Description
biliary plastic stent placement
Primary Outcome Measure Information:
Title
Documented change in Quality Of Life
Description
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.
Time Frame
180 days after stent insertion
Secondary Outcome Measure Information:
Title
Documented change in symptoms and concerns specific for patients with MBDO
Description
An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.
Time Frame
180 days after stent placement
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Sherman, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glen A Lehman, MD
Organizational Affiliation
Indiana Univesity Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Frankes, MD
Organizational Affiliation
Rockford GE Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Johanson, MD
Organizational Affiliation
Rockford GE Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tahir Qaseem, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Howell, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Stenting Malignant Jaundice for Quality of Life
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