Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Paused · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Pancreatic Diseases
In brief
This phase II/III trial compares the effect octreotide and the duration of antibiotic treatment has on outcomes in patients undergoing a Whipple procedure. A Whipple procedure is a surgery that may remove all or part of the pancreas, part of the intestines, stomach and gallbladder. Leakage from the pancreas due to damaged pancreatic ducts (fistula) is a major complication following pancreatic resection often delaying further treatment and increasing hospital stays. Antibiotics along with octreotide, which works by inhibiting pancreatic secretions, is standard treatment for a pancreatic fistula. This study will determine if the length of antibiotic treatment decreases the rate of fistulas and shortens hospital stays.
Key facts
- Study ID
- NCT04329039
- Run by
- Mayo Clinic
- People needed
- 103
- Starts
- 2020-11-17
- Expected to finish
- 2027-05-06
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing a Whipple procedure for various diagnoses (neuroendocrine tumors, adenocarcinoma, benign cystic neoplasms, duodenal and ampullary malignancies, etc) who are deemed intermediate-high risk as per our institutional protocol as shown above.
- Patients > 18 years of age
You may not qualify if…
- Negligible and low risk patients
- All patients undergoing arterial resection.
- Age <18 years
- Currently pregnant
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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