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Moray Micro Forceps and Pancreatic Cyst

NCT04200131 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-11

No results posted yet for this study

Summary

The prevalence of pancreatic cysts in the general population is high close to 1%. The diagnosis is most of the time fortuitous thanks to the improvement of the imaging resources available. These lesions include a large number of entities, some of with malignant potential. Mucinous lesions present a high risk of tumor transformation, justifying surgery, which is sometimes heavy. It appears essential to select the best patients to benefit from this type of treatment. For this purpose, the accuracy of the diagnostic means must be optimal. The Fine Needle Aspiration under Endoscopic ultrasound, validated in this context, have a low complication rate. It allows a cytological evaluation and analysis of tumor markers measurements in cystic fluid. However, cytopathological evaluation is only contributing in 1/3 to half of cases. The assays of markers (including the main one ACE) have high specificities but high insufficient sensitivities (less than 50%). Molecular techniques (K-RAS mutation in particular), of variable availability, allow to increase the sensitivity in association with the other diagnostic parameters. But the rate of false negatives remains above 20% to date. A diagnostic means to obtain a histology of the cyst wall would reduce considerably the risk of error.

The Moray™ micro forceps is forceps that aims to provide a tissue sample of the wall of the pancreatic cyst. It is inserted into a commonly used 19 Gauge needle during the puncture of the cyst under endoscopic ultrasound. It could increase the accuracy diagnosis of the procedure. These forceps has recently become available to the practitioner and has obtained the CE marking.

To date, no quality multi-center prospective evaluation has determined the capacity of to obtain a histology of the pancreatic cystic walls by this technique. Its safety must be also be accurately assessed.

Conditions

  • Pancreas Cyst

Interventions

DIAGNOSTIC_TEST

Biopsy of the cyst wall with the Moray™ forceps.

Tissue sample of the wall of the pancreatic cyst with micro Moray™ forceps during an ultrasound-guided puncture of a pancreatic cyst with a 19G needle.

Sponsors & Collaborators

  • VANBIERVLIET

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2022-07-01
Completion
2023-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200131 on ClinicalTrials.gov