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
• 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
• 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

Related Conditions & MeSH terms

• Pancreatic Diseases

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