ClinicalTrials.Veeva

Menu

Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

Mayo Clinic logo

Mayo Clinic

Status and phase

Invitation-only
Phase 3
Phase 2

Conditions

Pancreatic Diseases

Treatments

Drug: Somatostatin analog

Study type

Interventional

Funder types

Other

Identifiers

NCT04329039
NCI-2022-11062 (Registry Identifier)
18-010128

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups, including a placebo group

Group 1
Active Comparator group
Description:
Active somatostatin analogue combined with perioperative antibiotics
Treatment:
Drug: Somatostatin analog
Group 2
Placebo Comparator group
Description:
Placebo combined with perioperative antibiotics
Treatment:
Drug: Somatostatin analog

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems