Quality Of Life in Patients With Malignant Biliary Obstruction

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Gallbladder Cancer; Bile Duct Cancer; Liver Cancer

Treatments: Behavioral: questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT00579865

04-036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

124 participants in 2 patient groups

Group A

Description:

Patients scheduled for percutaneous drainage

Treatment:

Behavioral: questionnaires

Behavioral: questionnaires

Group B

Description:

Patients scheduled for a surgical bypass or resection of a high bile duct tumor.

Treatment:

Behavioral: questionnaires

Behavioral: questionnaires