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New dissolving stent aims to prevent dangerous leaks after pancreatic surgery

NCT ID NCT05668260

Disease control Sponsor: Ospedale San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether placing a biodegradable internal stent during pancreatic surgery can prevent a common and serious complication called a pancreatic fistula. 122 high-risk patients were randomly assigned to receive the stent or no stent. The goal was to see if the stent reduces the rate of clinically relevant fistulas.

What this could mean

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

Active substance
Biodegradable internal pancreatic stent (ARCHIMEDES™)
What this could lead to
If effective, this stent could reduce the risk of a serious pancreatic leak after surgery, leading to fewer complications and faster recovery.
What could go wrong
This is a small, completed study (122 patients) with no blinding. The stent may not lower fistula rates and could cause its own complications like displacement or blockage.

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

122 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2026

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: * Age ≥18 * Patients who undergo pancreatoduodenectomy (PD) * Informed Consent Exclusion Criteria: * Previous distal pancreatectomy * Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score \< 7)

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As listed by the trial registrant

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

Clinically relevant postoperative pancreatic fistula Internal biodegradable pancreatic stent Pancreatoduodenectomy

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    Milan, Milan, 20132, Italy

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