Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

March 30, 2026 updated by: Michael L. Kendrick, MD, Mayo Clinic

Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Active somatostatin analogue combined with perioperative antibiotics
Drug: Somatostatin analog
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
Other Names:
  • Arm A
Placebo Comparator: Group 2
Placebo combined with perioperative antibiotics
Drug: Somatostatin analog
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
Other Names:
  • Arm A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: Up to 90 days
Assessed by the length of hospital stay (days) following pancreatic surgery.
Up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pancreatic fistula
Time Frame: Up to 90 days
defined as postoperative drain output of fluid with amylase content more than 3 times the maximum normal serum value and exceeding 10 mL/24 h for more than 3 days
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Michael L Kendrick, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Estimated)

May 6, 2027

Study Completion (Estimated)

May 6, 2027

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-010128
  • NCI-2022-11062 (Registry Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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