Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

NCT ID: NCT04329039

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be randomized on a 1:1 ratio to either somatostatin analogues with perioperative antibiotics vs. placebo with perioperative antibiotics

Study Groups

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Group 1

Active somatostatin analogue combined with perioperative antibiotics

Group Type ACTIVE_COMPARATOR

Somatostatin analog

Intervention Type DRUG

Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics

Group 2

Placebo combined with perioperative antibiotics

Group Type PLACEBO_COMPARATOR

Somatostatin analog

Intervention Type DRUG

Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics

Interventions

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Somatostatin analog

Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics

Intervention Type DRUG

Other Intervention Names

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Arm A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael L Kendrick, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2022-11062

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-010128

Identifier Type: -

Identifier Source: org_study_id

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