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New combo therapy aims to slash deadly leaks after pancreatic cancer surgery

NCT ID NCT07262957

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether giving three treatments together—two medicines and a surgical patch—can lower the risk of major complications after Whipple surgery for pancreatic cancer and other tumors. The study includes 400 high-risk patients with a small pancreatic duct. If successful, this approach could become a new standard to help patients recover faster and avoid life-threatening leaks.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * Elective pancreatoduodenectomy for any indication (both minimally invasive and open) * Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI\* * 18 years of age or older * Signature of informed consent * In the opinion of the investigator, the patient is eligible for the administration of hydrocortisone and octreotide, based on contraindications, warnings, and precautions as listed in the respective SmPCs Exclusion Criteria: * Age \< 18 years * Pregnancy or current breastfeeding * Known allergy or hypersensitivity to hydrocortisone or octreotide * Systemic fungal infection * Concomitant use of strong CYP3A4 inhibitors or moderate-to-strong inducers that cannot be discontinued (see CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu)) * Inhibitors must be discontinued ≥7 days before randomization * Inducers must be discontinued ≥28 days before randomization

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Conditions

The condition(s) this trial relates to.

ampulla of vater adenocarcinoma carcinoma of duodenum cholangiocarcinoma duodenum cancer exocrine pancreatic carcinoma Fistula neuroendocrine neoplasm pancreatic adenocarcinoma pancreatic ductal adenocarcinoma Pancreatic Intraductal Neoplasms pancreatic intraductal papillary-mucinous neoplasm pancreatic mucinous-cystic neoplasm pancreatic neuroendocrine tumor pancreatitis

As listed by the trial registrant

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

Ampulla of vater adenocarcinoma Cholangio carcinoma Duodenal carcinoma Ipmn, pancreatic Mucinous cystic neoplasm Neuro endocrine tumours Pancreas adenocarcinoma Pancreas head cancer Pancreatitis Pdac - pancreatic ductal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.