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Pancreatic surgery showdown: which drug prevents leaks best?

NCT ID NCT03000946

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether somatostatin is better than octreotide at preventing pancreatic fistulas—a common and serious leak after pancreatic surgery. Researchers enrolled 655 adults undergoing pancreatic surgery and gave one of the two drugs for about a week. The goal was to see which drug reduces the risk of moderate to severe fistulas.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Somatostatin and octreotide
What this could lead to
If somatostatin proves more effective, it could reduce serious complications after pancreatic surgery, improving recovery and lowering healthcare costs.
What could go wrong
This is a completed phase 3 trial, so results are available, but the benefit may be modest or not apply to all surgery types. Both drugs have known side effects like nausea or blood sugar changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

655 people

The number who actually took part.

Started

May 2017

Finished

Feb 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men or women aged 18 years or greater * Signed informed consent * Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy Exclusion Criteria: * Patient with radiation therapy * Patient with neoadjuvant chemotherapy within 4 weeks before surgery * Pregnancy * Breastfeeding * Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator * Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion * Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (LAR) or s.c. formulations * Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations * Patients treated by ciclosporin * Patient without health insurance or social security * Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study

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Conditions

The condition(s) this trial relates to.

Pancreatic Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic surgery

Contacts and locations

Locations

  • Cochin Hospital

    Paris, Paris, 75014, France

  • La Pitié Salpêtrière Hospital

    Paris, 75013, France

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