Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

NCT04329039 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 18-010128NCI-2022-11062
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Diseases

Outcome Measures

Primary Outcomes (1)

• This study aims to determine whether duration of antibiotic therapy coupled with octreotide leads to reduction of the severity or occurrence of pancreatic fistula.

  To compare the active study medication with placebo to see if there is a reduction in the active drug arm in occurrence or pancreatic fistula

  During operative time plus 2 to 5 days post op

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Active somatostatin analogue combined with perioperative antibiotics

Drug: Somatostatin analog

Group 2

PLACEBO COMPARATOR

Placebo combined with perioperative antibiotics

Drug: Somatostatin analog

Interventions

Somatostatin analog DRUG

Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics

Also known as: Arm A

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Diseases

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Michael L Kendrick, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized on a 1:1 ratio to either somatostatin analogues with perioperative antibiotics vs. placebo with perioperative antibiotics
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: November 17, 2020
• Primary Completion: February 7, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)