Pancreas CystMOBIDYCNCT04200131
Moray Micro Forceps and Pancreatic Cyst
A study testing Biopsy of the cyst wall with the Moray™ forceps. in people with Pancreas Cyst, run by VANBIERVLIET at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cyst
- What is being tested?
- Biopsy of the cyst wall with the Moray™ forceps.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2020to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pancreas Cyst
- Being tested
- Biopsy of the cyst wall with the Moray™ forceps.
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Moray micro-forceps | Experimental | Not described Receives: Diagnostic Test: Biopsy of the cyst wall with the Moray™ forceps. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 10
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Quality of the sample
Determined by the proportion of samples with a histological analyzable surface by the pathologist.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start22 Jan 2020
- Primary completion1 Jul 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VANBIERVLIET
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200131
- Sponsor's protocol ID
- SFED N 133
- Acronym
- MOBIDYC
- Status last verified
- May 2022
- First submitted
- 3 Dec 2019
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Diagnostic Value of the Moray Micro Forceps in the Management of Pancreatic Cysts.
- ClinicalTrials.gov ID
- NCT04200131
- Acronym / sponsor ID
- MOBIDYC / SFED N 133
- Conditions
- Pancreas Cyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VANBIERVLIETUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moray micro-forceps | Experimental | Diagnostic Test: Biopsy of the cyst wall with the Moray™ forceps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Moray micro-forceps |
Primary outcome
Obtaining histological diagnosis by using "The Moray" micro forceps.
Time frame: Day 10
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.
5 secondary outcomes
The diagnostic accuracy of the technique (The Moray" micro forceps)
Time frame: 6 months
Emergent Adverse Events of the technique (the Moray micro-forceps)
Time frame: Day 0 and after 1 month
Technical success of the Moray micro-forceps
Time frame: Day 0
Satisfaction of the technique (Moray micro-forceps) on the management of pancreatic cyst
Time frame: 6 months
Quality of the sample
Time frame: Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Related trials for Pancreas Cyst
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingObservational study
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Pancreatic Cyst
RecruitingPhase 1
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
Pancreatic Cyst, Pancreatic Mucinous Cystic Neoplasm
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of the cyst wall with the Moray™ forceps. in people with Pancreas Cyst, run by VANBIERVLIET at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining histological diagnosis by using "The Moray" micro forceps. (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.