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NCT04329039 Clinical Trial

Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Pancreatic Diseases Clinical Trial

Official title:
Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04329039
Other study ID # 18-010128
Secondary ID NCI-2022-11062
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date November 17, 2020
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 400
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Somatostatin analog
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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