Pancreatic DiseasesPhase 2/3NCT04329039
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
A Phase 2/3 study testing Somatostatin analog in people with Pancreatic Diseases, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- Somatostatin analog
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 6 May 2027
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Negligible and low risk patients
- All patients undergoing arterial resection.
- Age <18 years
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
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.
- Conditions
- Pancreatic Diseases
- Being tested
- Somatostatin analog
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatostatin analogDrug
Also called Arm A
Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Active somatostatin analogue combined with perioperative antibiotics Receives: Drug: Somatostatin analog |
| Group 2 | Placebo comparator | Placebo combined with perioperative antibiotics Receives: Drug: Somatostatin analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Assessed by the length of hospital stay (days) following pancreatic surgery.
Measured: 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
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start17 Nov 2020
- Primary completion6 May 2027 (estimated)
- Study completion6 May 2027 (estimated)
Why it stopped: study paused for interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael L. Kendrick, MD, Mayo Clinic
- Investigators
- Michael L Kendrick, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329039
- Sponsor's protocol ID
- 18-010128
- Other IDs
- NCI-2022-11062
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2020
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
- ClinicalTrials.gov ID
- NCT04329039
- Acronym / sponsor ID
- 18-010128
- Conditions
- Pancreatic Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: study paused for interim analysis
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Somatostatin analogActive somatostatin analogue combined with perioperative antibiotics |
| Group 2 | Placebo comparator | Drug: Somatostatin analogPlacebo combined with perioperative antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Negligible and low risk patients
- All patients undergoing arterial resection.
- Age <18 years
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatostatin analogAlso: Arm ASomatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics | Drug | Group 1, Group 2 |
Primary outcome
Length of Hospital Stay
Time frame: Up to 90 days
Assessed by the length of hospital stay (days) following pancreatic surgery.
1 secondary outcome
Incidence of pancreatic fistula
Time frame: Up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Kendrick, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Somatostatin analog in people with Pancreatic Diseases, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.