Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Mayo Clinic

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Pancreatic Diseases

Treatments: Drug: Somatostatin analog

Study type: Interventional

Funder types: Other

Identifiers

NCT04329039

NCI-2022-11062 (Registry Identifier)

18-010128

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Negligible and low risk patients
• All patients undergoing arterial resection.
• Age <18 years
• Currently pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

Active somatostatin analogue combined with perioperative antibiotics

Treatment:

Drug: Somatostatin analog

Group 2

Placebo Comparator group

Description:

Placebo combined with perioperative antibiotics

Treatment:

Drug: Somatostatin analog