None listed
Conditions
Brief summary
The primary purpose of this pilot trial is to evaluate whether a full-scale clinical trial for gastrografin is feasible, and to provide an initial estimate of the efficacy of gastrografin for the resolution of malignant bowel obstruction (MBO). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with MBO. Study details All participants enrolled in this pilot trial will receive the same treatment. This involves a single oral dose of gastrografin administered as a 100ml solution. Participants will then be followed up for 5 days to assess whether the treatment has reached the bowel, whether it has been effective in clearing the obstruction and any side effects which may have occurred. It is hoped that the findings from this trial can be used to inform future clinical trials on the use of gastrografin in palliative care.
Interventions
Open label
Drug - Gastrografin - 10g sodium diatrizoate and 66g meglumine diatrizoate per 100mls
Dose - 100mls orally
Dose - Single dose
Sponsors
Mater Misericordiae Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Age > 18 years old -Admitted to Mater Misericordiae Ltd, Brisbane or St Vincent’s Private Hospital, Brisbane -Meeting criteria for MBO a) Clinical evidence of bowel obstruction – history, physical examination, and/or b) Radiographic evidence of bowel obstruction distal to ligament of Treitz (at the junction of the duodenum and jejunum) and c) Known intra-abdominal/pelvic primary cancer with incurable disease or non-intra-abdominal cancer with intra-peritoneal disease -MBO with no indication for any acute intervention (surgery, endoscopy, chemotherapy, radiotherapy) -Have received standard conservative management for at least 24 hours with no resolution of MBO -Capacity to provide consent
Exclusion criteria
-Patients with sepsis, signs of perforation or acute abdomen on examination -Pregnancy -Known allergy to Gastrografin 'Registered Trademark' or iodine -Evidence of gross gastric distension on radiologic examination. -Presence of a venting or feeding gastrostomy or jejunostomy (presence of an NG tube does not exclude patients and may be advisable in patients with frequent large volume vomits) -Biochemically proven thyrotoxicosis -Diagnosed with faecal loading ONLY -Known oesophageal or gastrointestinal fistula -Swallowing deficit (clinician discretion) -Patient whom are clinically dehydrated (clinician discretion) -Clinician judgement that patient is at high risk of aspiration
Outcome results
None listed