Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Tumor Puncture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

EUS-FNB with 20-gauge Procore® needle

Intervention Type PROCEDURE

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

EUS-FNB with 22-gauge Acquire® needle

Intervention Type PROCEDURE

Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®

Interventions

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EUS-FNB with 20-gauge Procore® needle

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

Intervention Type PROCEDURE

EUS-FNB with 22-gauge Acquire® needle

Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No