Back to resultsSomatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Primary Purpose
Pancreatic Diseases
Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Somatostatin analog
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Diseases
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
Active somatostatin analogue combined with perioperative antibiotics
Placebo combined with perioperative antibiotics
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04329039
Brief Title
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Official Title
Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
Masking
Participant
Masking Description
Patients will be randomized on a 1:1 ratio to either somatostatin analogues with perioperative antibiotics vs. placebo with perioperative antibiotics
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Active somatostatin analogue combined with perioperative antibiotics
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo combined with perioperative antibiotics
Intervention Type
Drug
Intervention Name(s)
Somatostatin analog
Other Intervention Name(s)
Arm A
Intervention Description
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
Primary Outcome Measure Information:
Title
This study aims to determine whether duration of antibiotic therapy coupled with octreotide leads to reduction of the severity or occurrence of pancreatic fistula.
Description
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
Time Frame
During operative time plus 2 to 5 days post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Kendrick, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
We'll reach out to this number within 24 hrs