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Could a radiofrequency knife beat the stapler for safer pancreas surgery?

NCT ID NCT04402346

Disease control Sponsor: Patricia Sanchez Velazquez 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial tests whether using a radiofrequency device to cut the pancreas during distal pancreatectomy reduces the chance of a pancreatic fistula (a leak of digestive fluids) compared to the standard stapler method. About 112 adults having this surgery for benign or malignant tumors will be randomly assigned to one of the two techniques. The main goal is to see which method leads to fewer fistulas, with follow-up on complications and recovery.

What this could mean

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

Active substance
radiofrequency-assisted pancreas transection or stapler-assisted pancreas transection
What this could lead to
If radiofrequency transection proves better, it could reduce the risk of pancreatic fistula, a serious complication after pancreas surgery.
What could go wrong
This is a single trial with 112 participants, and results may not apply to all patients or surgical settings. The procedure also carries its own risks.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

112 people

The number who actually took part.

Started

Feb 2021

Finished

May 2025

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: * Solid or cystic, benign or malign pancreas neoplasms. * Patients undergoing a distal pancreatectomy, i.e pancreas transection beyond \> 2 cm from the SMV (assessed by computer tomography or RM) with or without splenectomy * Both open and laparoscopic approaches are valid. Exclusion Criteria: * Patients who required a pancreatectomy with transection at the level of the neck. * Non-intervention group: only stapler transection will be accepted, other pancreatic transection methods will be excluded. * Patients ASA≥IV * Absence of informed consent * Underage (\<18 years)

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Conditions

The condition(s) this trial relates to.

Pancreatic Fistula pancreatic neoplasm

As listed by the trial registrant

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

Pancreas; fistula

Contacts and locations

Locations

  • Parc de Salut Mar de Barcelona- Hospital del Mar

    Barcelona, Catalonia, 08019, Spain

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