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New surgery combo for pancreatic cancer aims to cut complications and speed recovery

NCT ID NCT05843877

Disease control Sponsor: Technische Universität Dresden 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares two surgical approaches for people with pancreatic cancer who are at high risk for a serious complication called a pancreatic fistula. One group gets the standard surgery that removes only the tumor-affected part of the pancreas. The other group has the entire pancreas removed and receives a transplant of their own insulin-making cells (islets) into the liver. The goal is to see if the more extensive surgery reduces complications and helps patients start additional cancer treatments faster.

What this could mean

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

Active substance
autologous pancreatic islet cells
What this could lead to
If successful, this approach could reduce serious complications after pancreatic cancer surgery and help patients start additional cancer treatments sooner.
What could go wrong
This is a small early-phase trial with only 32 participants, so results may not apply to all patients. The islet transplant may not produce enough insulin, and patients will still need close monitoring.

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

About 32 people

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

Started

Jan 2025

Expected to finish

Jan 2028

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: * suspected or confirmed periampullary carcinoma (tumor) and indication for PPPD (pylorus-preserving pancreaticoduodenectomy) or Whipple surgery * high-risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreas and Pancreatic duct diameter \< 3 mm (preoperative and intraoperative confirmation) * written informed consent of the participant after successful Informed consent Exclusion Criteria: * patients on whom another procedure is to be performed simultaneously in addition to PPPD or Whipple surgery * confirmed other primary tumor * previous transplantation of an organ or tissue * known infection with HIV (HIV antibodies) * positive hepatitis C antibodies, positive hepatitis B surface antigens and hepatitis Bc antibodies * insulin-treated diabetes mellitus * history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure * concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion). * addiction or other medical conditions that do not allow the subject to understand the nature and not be able to appreciate the nature, scope and possible consequences of the trial * pregnant or breastfeeding women * women of childbearing age, except for women who meet the following criteria: 1. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH \> 40 U/ml) 2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy) 3. Regular and correct use of a contraceptive method with an failure rate \< 1% per year 4. Sexual abstinence 5. Vasectomy of the partner * evidence that the patient is unlikely to comply with the protocol

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Conditions

The condition(s) this trial relates to.

periampullary adenocarcinoma

As listed by the trial registrant

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

Periampullary cancer Postoperative pancreatic fistula

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

  • University Hospital Carl Gustav Carus Technische Universität Dresden

    RECRUITING

    Dresden, Germany

More trials for these conditions

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