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Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

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ClinicalTrials.gov Identifier: NCT04329039
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Michael L. Kendrick, Mayo Clinic

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
Pancreatic Diseases Drug: Somatostatin analog Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : July 16, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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 Name: Arm A

Placebo Comparator: Group 2
Placebo combined with perioperative antibiotics
Drug: Somatostatin analog
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
Other Name: Arm A




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. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329039


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael L Kendrick, MD Mayo Clinic
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Responsible Party: Michael L. Kendrick, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04329039    
Other Study ID Numbers: 18-010128
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs