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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Papillary and Mucinous Intraductal Tumours of the Pancreas
• Intervention / Treatment: Diagnostic test: SMI (Superb Microvascular Imaging)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertrand NAPOLEON, MD; Phone Number: + 33 4 78 75 67 43; Email: dr.napoleon@wanadoo.fr

Study Locations

• France
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
    • Contact: Bertrand NAPOLEON, MD; Phone Number: + 33 4 78 75 67 43; Email: dr.napoleon@wanadoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMI group; Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)	Diagnostic test: SMI (Superb Microvascular Imaging); Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: SMI; papillary and mucinous intraductal tumours of the pancreas
• Other Study ID Numbers: 2026-A00625-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No