Gallbladder CancerNCT00579865
Quality Of Life in Patients With Malignant Biliary Obstruction
An observational study of Gallbladder Cancer and Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Cancer, Liver Cancer, Bile Duct Cancer
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- 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
Show all 9Show fewer
- Able to speak and read English
- Able to comprehend and execute informed consent
- Prior intervention for MBO not exclusionary
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction
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.
Read the 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.
- Conditions
- Gallbladder Cancer, Liver Cancer, Bile Duct Cancer
- Being tested
- questionnaires
- Keywords
- Quality of Life
- Medical subject headings
- Gallbladder Neoplasms, Liver Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.
questionnairesBehavioural
complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients scheduled for percutaneous drainage Receives: Behavioral: questionnaires | |
| Group B | Patients scheduled for a surgical bypass or resection of a high bile duct tumor. Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: conclusion of the study
Secondary outcomes (1)
To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startMay 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Piera Robson, RN, BSN, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579865
- Sponsor's protocol ID
- 04-036
- Status last verified
- Jan 2010
- First submitted
- 20 Dec 2007
- Last updated
- 14 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT00579865
- Acronym / sponsor ID
- 04-036
- Conditions
- Gallbladder Cancer, Liver Cancer, Bile Duct Cancer
- Keywords
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Behavioral: questionnairesPatients scheduled for percutaneous drainage |
| Group B | – | Behavioral: questionnairesPatients scheduled for a surgical bypass or resection of a high bile duct tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (9 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairescomplete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. | Behavioural | Group A |
| questionnairescomplete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks. | Behavioural | Group B |
Primary outcome
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.
Time frame: conclusion of the study
1 secondary outcome
To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)
Time frame: conclusion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piera Robson, RN, BSN principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Cancer and Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: conclusion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.