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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03567863
Other study ID # 2018-A00276-49
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 24, 2018
Est. completion date September 29, 2019

Study information

Verified date September 2019
Source Société Française d'Endoscopie Digestive
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter randomized prospective study

Criteria for inclusion:

Patients admitted for EUS-FNB of a pancreatic mass

Goals of the study:

To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific.

Main criterion:

- Biopsy core length of target tissue obtained by needle pass

Number of patients:

60 patients

Duration of the study:

1 year


Description:

Type of study:

Multicenter randomized prospective study

Criteria for inclusion:

Patients admitted for ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY (EUS-FNB) of a pancreatic mass

Exclusion criteria:

Patients with an extra-pancreatic mass puncture Echendoscopic puncture contraindication or vascular interposition

Goals of the study:

To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific.

Evaluation criteria :

Main criterion:

- Biopsy core length of target tissue obtained by needle pass

Secondary criteria

- Presence of a core biopsy specimen

- Sensitivity of EUS-FNB for the diagnosis of adenocarcinoma of the pancreas

- False negative rate, Negative predictive value for the diagnosis of pancreatic adenocarcinoma

- Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All core biopsy specimens

- Success rate of isolation of tumor cells and determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes

- Immediate complications of puncture

- Variation in the quality of the puncture following the trans-duodenal or trans-gastric access route

- Technical failure rate of puncture

- Optional: inter and intra-observer evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle passage)

Number of patients:

60 patients

Duration of the study:

1 year


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 29, 2019
Est. primary completion date September 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Patient admitted to one of the investigative centers for endoscopic pancreatic puncture during the period from April 1, 2018 to April 1, 2019

- Patient whose age is greater than or equal to 18 years and less than 90 years

- Patient ASA 1, ASA 2, ASA 3 (ASA: American Society of Anaesthesiologists Classification)

- Lack of participation in another clinical study

- Signed informed consent

Exclusion Criteria:

- Patients punctured with an extra-pancreatic mass

- Patient under the age of 18 or over 90

- Patient ASA 4, ASA 5

- Pregnant woman

- Patient with coagulation abnormalities preventing puncture: TP <50%, Platelets <50000 / mm3, effective anticoagulation in progress, clopidogrel in progress

- Vascular or ductal or surgical fixation (Billroth II, Roux in Y) preventing endoscopic access to the lesion to be punctured

- Patient unable to personally consent

Study Design


Intervention

Device:
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)

Locations

Country Name City State
France David Karsenti Charenton-le-Pont Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative length of tissue core biopsies per needle pass cumulative length of tissue core biopsies per needle pass in mm in the 7 days after procedure
Secondary Presence of core biopsy specimen Presence of core biopsy specimen in the 7 days after procedure
Secondary Sensitivity EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas in the 7 days or 6 months
Secondary Specificity EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas in the 7 days or 6 months
Secondary Positive Predictive Value EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas in the 7 days or 6 months
Secondary Negative Predictive Value EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas in the 7 days or 6 months
Secondary Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies 6 months
Secondary Success rate of isolation of tumor cells Success rate of isolation of tumor cells 6 months
Secondary Morbidity Puncture Morbidity (acute pancreatitis, haemorrhage) 7 days
Secondary Feasibility Technical failure rate of puncture because of a impossibility to access to pancreatic mass with the needle (due to the needle stiffness) during procedure
Secondary inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass) inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass) 7 days
Secondary determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes 6 months
Secondary intra-observer evaluation of the anatomopathological criteria used intra-observer evaluation of the anatomopathological criteria used 7 days
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