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Papillary and Mucinous Intraductal Tumours of the PancreasENDOKYSMILENCT07663734

Assessment of SMI (Superb Microvascular Imaging) for Characterising the Endocystic Material of Papillary Intraductal Mucinous Pancreatic Tumours (PIMPT)

A study testing SMI (Superb Microvascular Imaging) in people with Papillary and Mucinous Intraductal Tumours of the Pancreas, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

There are many types of pancreatic cysts, and papillary intraductal mucinous pancreatic tumours (PIMPTs) are among the most common. PIMPTs carry a risk of progressing to a cancerous lesion. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SMI (Superb Microvascular Imaging)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Jul 2026to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient referred for an endoscopic ultrasound assessment of a PIMPT
  • Patient with endocystic material of undetermined nature measuring 3 mm or more
  • Patient registered with or covered by the social security scheme
  • Patient who speaks French
  • Patient who has signed an informed consent form

Who cannot join

  • Patient whose lesion meets the criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration)
  • Patient for whom Sonovue is contraindicated
  • Pregnant woman
  • Vulnerable patient: an adult under guardianship, curatorship or other legal protection, or deprived of their liberty by a judicial or administrative decision
  • Patient admitted to hospital without consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bertrand NAPOLEON, MD contact

+ 33 4 78 75 67 43

dr.napoleon@wanadoo.fr

France1 site
  • Hôpital Privé Jean Mermoz

    Lyon, 69008

    Bertrand NAPOLEON, MD, + 33 4 78 75 67 43, dr.napoleon@wanadoo.fr

Other trials in France

About this study

There are many types of pancreatic cysts, and papillary intraductal mucinous pancreatic tumours (PIMPTs) are among the most common.

PIMPTs carry a risk of progressing to a cancerous lesion. To assess this risk, the key examination involves performing an endoscopic ultrasound combined with an injection of a contrast agent called Sonovue.

Read more

Superb Microvascular Imaging (SMI) is a new ultrasound modality that enables the analysis of PIMPTs without the need for a Sonovue injection.

The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an endoscopic ultrasound examination.

This technology is now available on the new EUS Aplio i800 console (Canon-Olympus), which bears the CE mark.

To date, no data have been published on the potential of SMI for analysing a PIMPT. This is why this clinical investigation is being conducted

Read the detailed description

Pancreatic cysts are becoming increasingly common in the general population. They are most often discovered incidentally during an imaging scan.

There are many types of pancreatic cystic lesions, but the most common are papillary intraductal mucinous pancreatic tumours (PIMPTs), serous cystadenomas (SCAs), mucinous cystic tumours (MCTs) (formerly known as mucinous cystadenomas), cystic neuroendocrine tumours, and solid and pseudopapillary tumours.

PIMPTs carry a risk of degeneration, which may arise from an initially benign wall-bound nodule (polyp) that can subsequently progress to a malignant lesion. The average rates of high-grade dysplasia/invasive carcinoma in surgical specimens of PIMPT from the secondary ducts and the main duct are 31% and 62% respectively. The presence of a wall-adherent nodule > 1 cm is a clear indication for pancreatic surgery to prevent neoplastic progression (or to treat it if it is already present within the nodule). However, PIMPTs also secrete mucus, which most often presents as a globule adhering to the wall, thus resembling a wall-adherent nodule.

The key examination for assessing a PIMPT is echoendoscopy, which enables the type of material present within the cyst to be characterised. The most sensitive standard Doppler technique (e-flow) is often unsuccessful (no visible vessels) or yields an inconclusive result, as the vessels present in the tissue nodules are very fine and have a very slow flow.

Currently, to distinguish mucus from a tissue nodule, an ultrasound contrast agent (Sonovue) is routinely used to detect microvascularisation. A tissue nodule takes up the contrast agent, whereas a mucus ball is avascular (no contrast uptake).

Superb Microvascular Imaging (SMI) is a new ultrasound mode that broadens the range of visible blood flow by revealing low-velocity microvascular flow. SMI is capable of visualising microvascular flow without the injection of contrast medium, unlike the current gold standard technique based on the injection of Sonovue.

The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an echoendoscopy examination. This technology is now available on the new Aplio i800 EUS console (Canon-Olympus).

To date, no data have been published on the potential of SMI to characterise the endocystic material of PIMPTs. This is why this clinical investigation is being conducted.

Being tested
SMI (Superb Microvascular Imaging)
Keywords
papillary and mucinous intraductal tumours of the pancreas, SMI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMI (Superb Microvascular Imaging)Diagnostic test

    Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)

Study groups in NCT07663734
Study groupRoleWhat they receive
SMI groupExperimentalImaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
Receives: Diagnostic Test: SMI (Superb Microvascular Imaging)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SMI sensitivity

    Sensitivity is defined as the number of true positives (positive diagnoses in patients with a tissue nodule) divided by the total number of patients with a tissue nodule

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663734
Sponsor's protocol ID
2026-A00625-46
Acronym
ENDOKYSMILE
Status last verified
Jun 2026
First submitted
17 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SMI (Superb Microvascular Imaging) in people with Papillary and Mucinous Intraductal Tumours of the Pancreas, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bertrand NAPOLEON, MD (+ 33 4 78 75 67 43, dr.napoleon@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SMI sensitivity (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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