Moray Micro Forceps and Pancreatic Cyst

NCT04200131 | Unknown

• 1 other identifier: SFED N 133
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The diagnostic accuracy of the technique (The Moray" micro forceps)

  6 months

• Emergent Adverse Events of the technique (the Moray micro-forceps)

  Day 0 and after 1 month

• Technical success of the Moray micro-forceps

  Day 0

• Satisfaction of the technique (Moray micro-forceps) on the management of pancreatic cyst

  6 months

• Quality of the sample

  Day 10

Study Arms (1)

Moray micro-forceps

EXPERIMENTAL

Diagnostic Test: Biopsy of the cyst wall with the Moray™ forceps.

Interventions

Biopsy of the cyst wall with the Moray™ forceps. 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.

Moray micro-forceps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VANBIERVLIET: lead

Study Sites (1)

University hospital of Archet II

Nice, 06202, France

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Endocopy, Principal Investigator, Medical doctor

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 16, 2019
• Study Start: January 22, 2020
• Primary Completion: July 1, 2022
• Study Completion: March 1, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

FR (1)