Moray Micro Forceps and Pancreatic Cyst

NCT ID: NCT04200131

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2023-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Moray micro-forceps

Group Type: EXPERIMENTAL

Biopsy of the cyst wall with the Moray™ forceps.

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age over 18 years old
• FNA of the cystic fluid indicated during an endoscopic ultrasound examination
• Abdominal CT and pancreatic MRI less than 3 months old, available
• Pancreatic cyst unilocular or with a macrolocule in case of multilocular cyst, of size ≥ to 20 mm of major axis with a clean wall.

Exclusion Criteria

• Contraindication to performing an upper endoscopic ultrasound
• Patient with known chronic calcifying pancreatitis, or suspected on the iconography available during the screening visit
• Patient taking an antiplatelet, or anticoagulant therapy including anti-vitamin K, direct oral anticoagulant, or heparin.
• Hemorrhagic disease, hemostasis and coagulation disorder (TP < 60%, TCA > 40 sec. and platelets < 60000/mm3), malignant hematopathy, chronic cirrhotic liver disease with Child Pugh B or C, acute or severe chronic renal failure (creatinine clearance < to 30 ml/min)
• Mental disability of the subject making participation in the trial impossible
• Patient not affiliated to a social security system
• Inability to understand or sign informed consent
• Serious adverse events
• Early termination of participation, withdrawal of voluntary informed consent of the patient
• Violation of protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VANBIERVLIET

OTHER

Sponsor Role: lead

Responsible Party

VANBIERVLIET

Director, Head of Endocopy, Principal Investigator, Medical doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University hospital of Archet II

Nice, , France

Countries

France

Other Identifiers

SFED N 133

Identifier Type: -

Identifier Source: org_study_id