Clinical trial NCT00579865: Quality Of Life in Patients With Malignant Biliary Obstruction
Official title: Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder Cancer
Liver Cancer
Bile Duct Cancer
Keywords: Quality of Life
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

Brief summary: You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.

Detailed description: Malignant biliary obstruction (MBO) may arise in patients with cholangiocarcinoma, pancreatic carcinoma, primary gallbladder carcinoma, hepatocellular carcinoma, or metastatic disease to the liver or portal lymph nodes. MBO is often accompanied by significant symptoms that may result in impairment of health-related quality of life (HRQL), including pruritus, fever, nutritional deficits, abdominal pain, nausea and vomiting, and fatigue. Approaches to the relief of MBO include surgical bypass and/or resection, percutaneous drainage with or without biliary stenting, or endoscopic stenting. The non surgical procedures may be done prior to attempted curative resection or for palliation in individuals with unresectable or recurrent disease.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of malignant biliary obstruction
* Radiologic or histologic evidence of MBO
* Percutaneous biliary drainage procedure planned or
* Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned
* KPS \>50%
* Age 18 years or greater
* Able to speak and read English
* Able to comprehend and execute informed consent
* Prior intervention for MBO not exclusionary

Exclusion Criteria:

* Unable to complete questionnaire due to performance status
* Proxy completion is not accepted
* Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument

Primary outcomes:
measure: To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Piera Robson, RN, BSN
role: PRINCIPAL_INVESTIGATOR
References: