2020-01-22
2022-07-01
2023-03
100
NCT04200131
Société Française d'Endoscopie Digestive
Société Française d'Endoscopie Digestive
INTERVENTIONAL
Moray Micro Forceps and Pancreatic Cyst
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-12-03 | N/A | 2022-05-10 |
2019-12-12 | N/A | 2022-05-11 |
2019-12-16 | N/A | 2022-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Moray micro-forceps | DIAGNOSTIC_TEST: Biopsy of the cyst wall with the Moray™ forceps.
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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