Stenting Malignant Jaundice for Quality of Life

NCT01459965 | Completed

• 1 other identifier: 9307-04
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bile Duct Neoplasms Malignant

Keywords

Jaundice; Biliary stents; Palliation; Quality of Life; Endoscopic Retrograde Cholangiography

Outcome Measures

Primary Outcomes (1)

• 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.

  180 days after stent insertion

Secondary Outcomes (1)

• Documented change in symptoms and concerns specific for patients with MBDO

  180 days after stent placement

Study Arms (2)

10 French Stent

ACTIVE COMPARATOR

10 French biliary plastic stent

Procedure: ERCP with 10 French biliary plastic stent placement

11.5 French stent

ACTIVE COMPARATOR

11.5 French biliary plastic stent

Procedure: ERCP with 11.5 French biliary plastic stent

Interventions

ERCP with 10 French biliary plastic stent placement PROCEDURE

Stent placement of a 10 French biliary plastic stent

10 French Stent

ERCP with 11.5 French biliary plastic stent PROCEDURE

biliary plastic stent placement

11.5 French stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• American College of Gastroenterology: collaborator

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  PMID: 23269313 DERIVED

MeSH Terms

Conditions

Jaundice

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• 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

  MaineHealth

  PRINCIPAL INVESTIGATOR

• Douglas Howell, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 26, 2011
• Study Start: July 1, 1993
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: October 26, 2011

Record last verified: 2011-10