Pancreatic Diseases
Conditions
Brief summary
This phase II/III trial compares the effect octreotide and the duration of antibiotic treatment has on outcomes in patients undergoing a Whipple procedure. A Whipple procedure is a surgery that may remove all or part of the pancreas, part of the intestines, stomach and gallbladder. Leakage from the pancreas due to damaged pancreatic ducts (fistula) is a major complication following pancreatic resection often delaying further treatment and increasing hospital stays. Antibiotics along with octreotide, which works by inhibiting pancreatic secretions, is standard treatment for a pancreatic fistula. This study will determine if the length of antibiotic treatment decreases the rate of fistulas and shortens hospital stays.
Interventions
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be randomized on a 1:1 ratio to either somatostatin analogues with perioperative antibiotics vs. placebo with perioperative antibiotics
Intervention model description
Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Up to 90 days | Assessed by the length of hospital stay (days) following pancreatic surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pancreatic fistula | Up to 90 days | defined as postoperative drain output of fluid with amylase content more than 3 times the maximum normal serum value and exceeding 10 mL/24 h for more than 3 days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael L Kendrick, MD
Mayo Clinic
Outcome results
None listed