Moray Micro Forceps and Pancreatic Cyst (MOBIDYC)

Histological Diagnostic Value of the Moray Micro Forceps in the Management of Pancreatic Cysts.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreas Cyst
• Intervention / Treatment: Diagnostic test: Biopsy of the cyst wall with the Moray™ forceps.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06202
    • University hospital of Archet II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: Moray micro-forceps	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obtaining histological diagnosis by using "The Moray" micro forceps.	Obtaining enough tissue material by using "The Moray" micro forceps allowing paraffin embedding, histological analysis and diagnosis according to the opinion of the pathologist. The ability of the micro-forceps to obtain a positive sample will be determined histologically. The proportion % of the positive samples (diagnosis from the pathologist) will correspond to the number of patients whose histological diagnosis is obtained according to the pathologist (tissue with presence of a chorion / extracellular matrix) divided by the total number of patients enrolled in this trial.	Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic accuracy of the technique (The Moray" micro forceps)	The diagnostic accuracy of the technique will be determinate by comparison between the results obtained after using the Moray micro forceps and diagnosis retained after surgery. If the surgery is not performed, the diagnostic accuracy will be determined by 3 independent experts by using the morphological results of the different iconographies, cytology, intracystic fluid dosages	6 months
Emergent Adverse Events of the technique (the Moray micro-forceps)	The emergent adverse events will be assessed (Moray micro forceps) by compilation of all adverse events occurring immediately or at 30 days post-procedure (hemorrhages, possible episodes of acute pancreatitis or infection) according to degree of the severity: slight, moderate, severity, and fatal( cotton's criterions).The proportion of patients presenting at least one morbid event during the biopsy and after post-procedure (immediately) will be calculated and compared by using Prescott test. In the same way, the delayed morbidity of the procedure as a whole will be described by the proportion of patients who had a morbid event delayed between the end of the procedure and Day 30.	Day 0 and after 1 month
Technical success of the Moray micro-forceps	Assessed by the proportion of patients whose procedure allow obtained a biopsy in absence of a technical incident: passage of the micro-forceps through the 19G needle, its opening, the acquisition of tissue material, and its removal from the needle at the end of the procedure.	Day 0
Satisfaction of the technique (Moray micro-forceps) on the management of pancreatic cyst	Estimated by the proportion of patients for which the decision by the monitoring experts was different after obtaining the result of the samples by the Moray micro-forceps compared to a usual support based on the techniques available today.	6 months
Quality of the sample	Determined by the proportion of samples with a histological analyzable surface by the pathologist.	Day 10

Collaborators and Investigators

• Sponsor: VANBIERVLIET

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Pancreatic Cyst; Cysts
• Other Study ID Numbers: SFED N 133

Drug and device information, study documents

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