drugset / Trial / NCT04329039

Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

NCT04329039

Phase 2/3 Suspended 103 enrolled Mayo Clinic
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2020-11-17
Primary completion
2027-05-06
Completion
2027-05-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Octreotide Peptide

Indications