Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Mayo Clinic

Status and phase: Invitation-only; 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

Researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.

Enrollment: 400 estimated 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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400 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