Status:
TERMINATED
Palliative Management of Inoperable Malignant Bowel Obstruction
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Malignant Bowel Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age.
- Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy.
- Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission.
- Patient must have an inoperable MBO
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.
Exclusion
- Evidence of complete bowel obstruction by imaging.
- Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded.
- Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment.
- Patients undergoing bowel surgery or stent placement for bowel obstruction.
- Those patients with MBO in setting of incarcerated hernia.
- Known history of QT prolongation syndrome or if QTc is \> 450 msec in males or \> 470 msec in females on baseline EKG within 2 weeks of enrollment.
- Lack of decision making capacity/delirium.
- Pregnant or nursing female participants.
- Actively suicidal patients.
- Acute cholecystitis
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04027348
Start Date
June 26 2019
End Date
September 3 2021
Last Update
November 29 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263