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Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04329039
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
89.5
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Somatostatin analog
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibioticsRandomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
Masking:
Single (Participant)
Masking Description:
Patients will be randomized on a 1:1 ratio to either somatostatin analogues with perioperative antibiotics vs. placebo with perioperative antibiotics
Primary Purpose:
Treatment
Official Title:
Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Actual Study Start Date :
Jul 16, 2019
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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. [During operative time plus 2 to 5 days post op]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael L. Kendrick, MD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04329039
    Other Study ID Numbers:
    • 18-010128
    First Posted:
    Apr 1, 2020
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Diseases
    Somatostatin

    Study Results

    No Results Posted as of Apr 22, 2022