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Trial registered on ANZCTR
Registration number
ACTRN12612000499886
Ethics application status
Approved
Date submitted
1/04/2012
Date registered
9/05/2012
Date last updated
9/05/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Research of quality of life trends for Malignant obstructive jaundice patients with different treatment methods
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Scientific title
Research of quality of life trends for Malignant obstructive jaundice patients with different treatment methods
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Secondary ID [1]
280260
0
Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant obstructive jaundice
286201
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Condition category
Condition code
Cancer
286411
286411
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0
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Biliary tree (gall bladder and bile duct)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
1.Our research group have developed the quality of life scale specific module about malignant obstructive jaundice patients (QLQ-MOJ11) on the basis of EORTC QLQ-C30 scale. So we apply both EORTC QLQ-C30 and QLQ-MOJ11 scale to evaluation the quality of life for patients with malignant obstructive jaundice from admission to three months discharge. The patiernts need to fill with the scale five times over this period. We use the methods of self-evaluation and telephone follow-up to assesment the QOL of malignant obstructive jaundice patients.
2.The purpose of collecting general information on the patient is to judgment the demographic characteristics and biochemical indicators of the impact on patient quality of life and survival time. So that we can predict the risk factors with death forpatients with malignant obstructive jaundice .
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Intervention code [1]
284591
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Not applicable
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
286857
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The patients should fill out the QLQ-C30 and QLQ-MOJ11 scale three times duration of hospital stay, including admission, seven days after treatment, before dicharge. We should collect general data about patients in this timepoint. We can get the influence factors of quality of life for patients with malignant obstructive jaundice.
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Timepoint [1]
286857
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admission, seven days after treatment, before discharge.
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Primary outcome [2]
287079
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We follow-up patients with malignant obstructive jaundice patients by telephone and outpatient review. Patients shoud still full out the QLQ-C30 and QLQ-MOJ11 scale after discharge, including one month dicharge, three months discharge. We combine the data about patients duration of hospital stay to analysis the trends of quality of life for patients with malignant obstructive jaundice.
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Timepoint [2]
287079
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admission, seven days after treatment, before discharge, one month discharge, three months discharge.
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Secondary outcome [1]
296812
0
We will measure the survival time and the risk factors of death for patients with malignant obstructive jaundice by COX proportional hazards model.
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Timepoint [1]
296812
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the first day after treatment, one month discharge, three months dischare, six months discharge, and so on, till the patients death.
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Eligibility
Key inclusion criteria
1) clinically diagnosed with primary bile duct cancer, gallbladder cancer, duodenal cancer, pancreatic cancer, bile duct cancer and metastatic carcinoma.
2) Serum bilirubin Serum Bilirubin thelarger than or equal to 17.1micromol / L.
3) Imaging studies confirmed the biliary obstruction.
4) informed consent of patients.
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Minimum age
18
Years
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Maximum age
No limit
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) past and current mental illness patients and consolidation of the heart, lungs and other major disorders.
2) can not understand the contents of the questionnaire, and patients with language barrier.
3) have been involved in the survey of patients.
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/03/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4041
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China
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State/province [1]
4041
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Funding & Sponsors
Funding source category [1]
285010
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University
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Name [1]
285010
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Second Military Medical University Graduate seedling Fund
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Address [1]
285010
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Second Military Medical University,No. 800,Xiangyin road, Yangpu District, Shanghai ,200438.
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Country [1]
285010
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China
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Primary sponsor type
Hospital
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Name
Eastern Hepatobiliary Surgery Hospital
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Address
Department of Nursing, Eastern Hepatobiliary Surgery Hospital,No.225,Changhai road,Yangpu District, Shanghai ,200438.
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Country
China
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Secondary sponsor category [1]
283895
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University
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Name [1]
283895
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Second Military Medical University
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Address [1]
283895
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Second Military Medical University,No. 800,Xiangyin road, Yangpu District, Shanghai ,200438.
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Country [1]
283895
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China
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287015
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Shanghai Eastern Hepatobiliary Surgery Hospital Ethics Committee
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Ethics committee address [1]
287015
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Eastern Hepatobiliary Surgery Hospital,No. 225,Changhai road,Yangpu District,Shanghai,200438.
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Ethics committee country [1]
287015
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China
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Date submitted for ethics approval [1]
287015
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01/03/2012
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Approval date [1]
287015
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31/03/2012
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Ethics approval number [1]
287015
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EHBHKY2012-002-9
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Summary
Brief summary
The patients with malignant obstructive jaundice in advanced disease have poor quality of life according the results of literature review and clinical observations, so the main purpose of this study is the use of the QLQ-C30 scale developed by the European cancer research and treatment organizations, and the group pre-developed in patients with malignant obstructive jaundice specific item pool (QLQ-MOJ11) the class of the patient's quality of life evaluation, and analysis of these patients the survival time and the risk factors for death during hospitalization and late follow-up results, the trend of quality of life drawing class for patients with different treatment methods.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33589
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Address
33589
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Country
33589
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Phone
33589
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Fax
33589
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Email
33589
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Contact person for public queries
Name
16836
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Lili
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Address
16836
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ICU,Eastern Hepatobiliary Surgery Hospital, No.225,Changhai road,Yangpu District ,Shanghai,200438.
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Country
16836
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China
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Phone
16836
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+8613817382212
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Fax
16836
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+86021-81875041
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Email
16836
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smallsweetlily@hotmail.com
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Contact person for scientific queries
Name
7764
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Zhihuizou
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Address
7764
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Department of Nursing,Eastern Hepatobiliary Surgery Hospital,No. 225,Changhai road,Yangpu District , Shanghai,200438.
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Country
7764
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China
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Phone
7764
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+8615618877623
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Fax
7764
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+86021-81875041
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Email
7764
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zouzhihui1999@163.com
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No information has been provided regarding IPD availability
Summary results
No Results
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