Mousquetaires: Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

Sponsor
Société Française d'Endoscopie Digestive (Other)
Overall Status
Completed
CT.gov ID
NCT03444051
Collaborator
(none)
68
1
9.5
7.2

Study Details

Study Description

Brief Summary

This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: EUS-FNB with 20-gauge Procore® needle
  • Procedure: EUS-FNB with 22-gauge Acquire® needle

Detailed Description

Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore®, and 34 with a 22-gauge Acquire®. Histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. Intra and inter-observer variability of this criterion was then evaluated.

Study Design

Study Type:
Observational
Actual Enrollment :
68 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 15, 2017

Arms and Interventions

Arm Intervention/Treatment
20-gauge Procore®

Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore® during the period study

Procedure: EUS-FNB with 20-gauge Procore® needle
Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle

22-gauge Acquire®

Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 22-gauge Acquire® during the period study

Procedure: EUS-FNB with 22-gauge Acquire® needle
Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®

Outcome Measures

Primary Outcome Measures

  1. pancreatic mass anatomopathological characterization [in the 7 days after procedure]

    pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included
Exclusion Criteria:
  • non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y reconstruction

  • coagulation disorders (such as partial thromboplastin time >42 seconds, prothrombin time [Quick value] <50%, platelet count <50 000/mm³), treatment with clopidogrel, pregnancy.

  • patients <18 years of age

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique PARIS-BERCY Charenton-le-Pont France 94220

Sponsors and Collaborators

  • Société Française d'Endoscopie Digestive

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KARSENTI, principal investigator, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier:
NCT03444051
Other Study ID Numbers:
  • Mousquetaires
First Posted:
Feb 23, 2018
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by KARSENTI, principal investigator, Société Française d'Endoscopie Digestive
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2018