Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001029088
Ethics application status
Not yet submitted
Date submitted
18/11/2010
Date registered
23/11/2010
Date last updated
23/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Gastrografin for Malignant Bowel Obstruction
Scientific title
A feasibility study for a randomized controlled trial of Gastrografin in the management of malignant bowel obstruction
Secondary ID [1] 253089 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant bowel obstruction 258652 0
Condition category
Condition code
Oral and Gastrointestinal 258790 258790 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 258846 258846 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Arm will receive both:
a. Standard palliative management of malignant bowel
obstruction and
b. One time oral dose of 100ml of sodium diatrozoate,
meglumine datrozoate solution (Gastrografin)
Intervention code [1] 257607 0
Treatment: Drugs
Comparator / control treatment
Placebo Group will receive both:
a. Standard palliative management of malignant bowel
obstruction and
b. One time oral dose (placebo) of 100ml of distilled water
flavoured with aniseed oil
Control group
Placebo

Outcomes
Primary outcome [1] 259659 0
Time from administration of gastrografin to resolution of malignant bowel obstruction signified by passage of flatus/stool.
Timepoint [1] 259659 0
30 minutes post intervention
6 hours post intervention
12 hours post intervention
24 hours post intervention
2 days post intervention
3 days post intervention
Secondary outcome [1] 266332 0
Patient reported status of symptoms. Patients will rate their symptoms (nausea, vomiting, abdominal pain) on a numerical rating score
Timepoint [1] 266332 0
Prior to intervention
30 minutes post intervention
6 hours post intervention
12 hours post intervention
24 hours post intervention
2 days post intervention
3 days post intervention
Secondary outcome [2] 266333 0
Total number of patients screened in 6 months
Timepoint [2] 266333 0
6 months after trial initiation
Secondary outcome [3] 266334 0
Number of patients who do not fit inclusion criteria including exclusion reason
Timepoint [3] 266334 0
6 months after trial initiation
Secondary outcome [4] 266335 0
Number of patients who meet study criteria and decline to enter trial including reason for denial
Timepoint [4] 266335 0
6 months after trial initiation
Secondary outcome [5] 266336 0
Number of eligible patients who are successfully entered into trial
Timepoint [5] 266336 0
6 months after trial initiation
Secondary outcome [6] 266337 0
Acceptability and tolerability of trial medication - Patients will be monitored while ingesting the medication and will also answer questions about tolerability of medication on a questionnaire.
Timepoint [6] 266337 0
30 minutes after study medication/placebo is administered
Secondary outcome [7] 266338 0
Number of patients whose bowel function return during the study period or after the study period. Patients will be asked on a questionnaire whether they have passed on any flatus/stool. The nursing log will also be checked for any bowel movements.
Timepoint [7] 266338 0
Prior to intervention
30 minutes post intervention
6 hours post intervention
12 hours post intervention
24 hours post intervention
daily until date of discharge for the patient
Secondary outcome [8] 266339 0
Number of randomized patient who do not complete the trial including reason for withdrawal
Timepoint [8] 266339 0
6 months after trial initiation
Secondary outcome [9] 266340 0
Length of hospital stay
Timepoint [9] 266340 0
6 months after trial initiation
Secondary outcome [10] 266341 0
30 day readmission rate
Timepoint [10] 266341 0
6 months after trial initiation

Eligibility
Key inclusion criteria
Inclusion Criteria
- Age >18 years
- Satisfy criteria for a MBO
- No indication for immediate surgery
- Able to understand the risks/benefits of the study
- Able to give informed written consent
- Any further treatment (surgery, chemotherapy,
radiotherapy, hormone therapy, biological/targeted
therapies) is deemed by relevant practitioners unlikely
to change the acute management of the bowel
obstruction.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
- Known allergic reaction to study medication or
iodine
- Grossly distended stomach on radiologic exam
- Venting or feeding gastrostomy or jejunostomy
- Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. The gastrografin and placebo will be packaged in identical 100ml bottles and each labelled with a study identification number, and successively registered patients will be allocated the next bottle in the sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly allocated to gastrografin or placebo on a 1:1 ratio. Randomisation will be blocked over time, and the list giving randomisation and study identification numbers will be provided to the pharmacy by the statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3047 0
New Zealand
State/province [1] 3047 0
Auckland

Funding & Sponsors
Funding source category [1] 258059 0
Government body
Name [1] 258059 0
Auckland District Health Board Charitable Trust
Country [1] 258059 0
New Zealand
Primary sponsor type
Individual
Name
Ian Bissett
Address
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 257251 0
Individual
Name [1] 257251 0
Anne O'Callaghan
Address [1] 257251 0
Department of Palliative Care
Auckland City Hospital
Building 8
Park Road, Grafton
Auckland 1142
Country [1] 257251 0
New Zealand
Other collaborator category [1] 251654 0
Individual
Name [1] 251654 0
Michael Findlay
Address [1] 251654 0
Cancer Trials New Zealand
Discipline of Oncology
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
Country [1] 251654 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260056 0
Ethics committee address [1] 260056 0
Ethics committee country [1] 260056 0
Date submitted for ethics approval [1] 260056 0
09/11/2010
Approval date [1] 260056 0
Ethics approval number [1] 260056 0

Summary
Brief summary
Malignant bowel obstruction (MBO) occurs when the bowel (gut) becomes blocked due to cancer. When the bowel is blocked, symptoms such as pain, nausea and vomiting occur. Doctors will try to relieve the blockage with surgery and control the cancer with chemotherapy or radiotherapy, wherever possible. If these treatments cannot be used, medicines can be given to decrease symptoms so that people feel better. In some cases the bowel may become partially unblocked and start working again.
In people where the cause of the bowel blockage is not cancer, a drug called gastrografin has been shown to help unblock the bowel faster. Gastrografin is therefore now commonly given to these people. At the moment we do not know whether gastrografin will help unblock the bowel when the cause is cancer. The reason for carrying out this trial is therefore to help us try and find out whether the addition of gastrografin to the other medicines that we use to control symptoms, will help get the bowel working, when the cause of the blockage is cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31914 0
Address 31914 0
Country 31914 0
Phone 31914 0
Fax 31914 0
Email 31914 0
Contact person for public queries
Name 15161 0
Ian Bissett
Address 15161 0
Department of Surgery
University of Auckand
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1142
Country 15161 0
New Zealand
Phone 15161 0
64 9 373 7599 ext 89821
Fax 15161 0
64 9 377 9656
Email 15161 0
[email protected]
Contact person for scientific queries
Name 6089 0
Ian Bissett
Address 6089 0
Department of Surgery
University of Auckand
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1142
Country 6089 0
New Zealand
Phone 6089 0
64 9 373 7599 ext 89821
Fax 6089 0
64 9 377 9656
Email 6089 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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