Trial Review

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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
Scientific title
Research of quality of life trends for Malignant obstructive jaundice patients with different treatment methods
Secondary ID [1] 280260 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant obstructive jaundice 286201 0
Condition category
Condition code
Cancer 286411 286411 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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 .
Intervention code [1] 284591 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286857 0
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.
Timepoint [1] 286857 0
admission, seven days after treatment, before discharge.
Primary outcome [2] 287079 0
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.
Timepoint [2] 287079 0
admission, seven days after treatment, before discharge, one month discharge, three months discharge.
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.
Timepoint [1] 296812 0
the first day after treatment, one month discharge, three months dischare, six months discharge, and so on, till the patients death.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4041 0
China
State/province [1] 4041 0

Funding & Sponsors
Funding source category [1] 285010 0
University
Name [1] 285010 0
Second Military Medical University Graduate seedling Fund
Address [1] 285010 0
Second Military Medical University,No. 800,Xiangyin road, Yangpu District, Shanghai ,200438.
Country [1] 285010 0
China
Primary sponsor type
Hospital
Name
Eastern Hepatobiliary Surgery Hospital
Address
Department of Nursing, Eastern Hepatobiliary Surgery Hospital,No.225,Changhai road,Yangpu District, Shanghai ,200438.
Country
China
Secondary sponsor category [1] 283895 0
University
Name [1] 283895 0
Second Military Medical University
Address [1] 283895 0
Second Military Medical University,No. 800,Xiangyin road, Yangpu District, Shanghai ,200438.
Country [1] 283895 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287015 0
Shanghai Eastern Hepatobiliary Surgery Hospital Ethics Committee
Ethics committee address [1] 287015 0
Eastern Hepatobiliary Surgery Hospital,No. 225,Changhai road,Yangpu District,Shanghai,200438.
Ethics committee country [1] 287015 0
China
Date submitted for ethics approval [1] 287015 0
01/03/2012
Approval date [1] 287015 0
31/03/2012
Ethics approval number [1] 287015 0
EHBHKY2012-002-9

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33589 0
Address 33589 0
Country 33589 0
Phone 33589 0
Fax 33589 0
Email 33589 0
Contact person for public queries
Name 16836 0
Lili
Address 16836 0
ICU,Eastern Hepatobiliary Surgery Hospital, No.225,Changhai road,Yangpu District ,Shanghai,200438.
Country 16836 0
China
Phone 16836 0
+8613817382212
Fax 16836 0
+86021-81875041
Email 16836 0
smallsweetlily@hotmail.com
Contact person for scientific queries
Name 7764 0
Zhihuizou
Address 7764 0
Department of Nursing,Eastern Hepatobiliary Surgery Hospital,No. 225,Changhai road,Yangpu District , Shanghai,200438.
Country 7764 0
China
Phone 7764 0
+8615618877623
Fax 7764 0
+86021-81875041
Email 7764 0
zouzhihui1999@163.com

No data has been provided for results reporting
Summary results
Not applicable