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New ultrasound could spare patients unnecessary pancreatic surgery

NCT ID NCT07657884

Diagnosis Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new ultrasound technique called SMI can accurately identify benign pancreatic cysts (serous cystadenomas). Currently, many patients with these harmless cysts undergo unnecessary surgery due to diagnostic uncertainty. The study will enroll 60 patients and compare SMI results with the current gold-standard test. If SMI works well, it could provide a safer, cheaper, and non-invasive way to diagnose these cysts.

What this could mean

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

Active substance
SMI (Superb Vascular Imaging) ultrasound
What this could lead to
If successful, SMI could become a safe, non-invasive way to diagnose benign pancreatic cysts, avoiding risky surgeries.
What could go wrong
This is a small, early-stage study with no published data yet. SMI may not be accurate enough to replace current methods.

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

About 60 people

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

Started

May 2026

Expected to finish

Nov 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: * Patient referred for confocal microscopy (nCLE) assessment of a pancreatic cyst of unknown origin * Patient with a cyst measuring more than 15 mm in diameter and at least one cyst cavity measuring ≥ 5 mm (to allow nCLE to be performed) * Patient registered with or covered by the National Health Service * French-speaking patient who has signed an informed consent form Exclusion Criteria: * Patient with calcifying chronic pancreatitis * Presence of a communication with the main pancreatic duct on MRI or endoscopic ultrasound * Patient whose lesion meets criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration) * Patient with a contraindication to endoscopic ultrasound-guided puncture (haemostatic disorder) * Patient with a known allergy to fluorescein (used in nCLE) * Pregnant woman * Patient under legal guardianship: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative order * Hospitalised patient without consent

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Conditions

The condition(s) this trial relates to.

Cystadenoma, Serous cystic tumor of the pancreas serous cystadenoma

As listed by the trial registrant

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

Serous cystadenoma

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

  • Hôpital Privé Jean Mermoz

    RECRUITING

    Lyon, 69008, France

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