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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
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 21, 2011
    Last Updated
    October 25, 2011
    Sponsor
    Indiana University
    Collaborators
    American Society for Gastrointestinal Endoscopy, American College of Gastroenterology
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    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

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