CClinicalTrials.gg
SuspendedNCT04329039Updated Apr 3, 2026

Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics

A Phase 2/3 interventional study of Somatostatin analog in Pancreatic Diseases, sponsored by Mayo Clinic. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Treatment

Why this study was suspended
study paused for interim analysis
Phase
Phase 2/3
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Diseases

Browse trials for

03

In context

Pancreatic Diseases

169 studies on the registry are indexed under Pancreatic Diseases; 62 are open to participants now.

This study's enrollment of 103 is close to the median of 102 across 84 interventional studies indexed under Pancreatic Diseases.

Browse Pancreatic Diseases studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria

  • Negligible and low risk patients
  • All patients undergoing arterial resection.
  • Age \<18 years
  • Currently pregnant
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
103 participants (actual)

Study arms

  • Active comparator
    Group 1

    Active somatostatin analogue combined with perioperative antibiotics

    Drug: Somatostatin analog

  • Placebo comparator
    Group 2

    Placebo combined with perioperative antibiotics

    Drug: Somatostatin analog

Interventions

  • DrugSomatostatin analog

    Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics

    Also known as: Arm A

06

What researchers measure

Primary outcomes

  1. Length of Hospital Stay

    Assessed by the length of hospital stay (days) following pancreatic surgery.

    Time frame: Up to 90 days

Secondary outcomes

  1. Incidence of pancreatic fistula

    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

    Time frame: Up to 90 days

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 14, 2022
  • Informed consent form · Dec 5, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04329039
Lead sponsor
Mayo Clinic
Responsible party
Michael L. Kendrick, MD (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Apr 1, 2020
Start date
Nov 17, 2020
Primary completion
May 6, 2027 (estimated)
Completion
May 6, 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Michael L Kendrick, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion