Gastrografin for Malignant Bowel Obstruction

A feasibility study for a randomized controlled trial of Gastrografin in the management of malignant bowel obstruction

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001029088

Enrollment

Registered

2010-11-23

Start date

2011-02-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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

Outcome results