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Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions

NCT06994611 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-06-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.

Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.

In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was \< 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.

Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.

Conditions

Interventions

PROCEDURE

MOSE application

The length of the tissue strips was judged using the specimen table and photographed for record. If the MVC of the first needle sample was ≥10mm, the tissue strip was placed into bottle A formalin for fixation. A second needle of tissue strip was pushed directly into the B-bottle formalin. If the first needle sample MVC was \< 10mm, the puncture was continued until the total length of sample MVC was ≥10mm, and all samples were placed into bottle A formalin.

PROCEDURE

Conventional processing

Two needles were punctured and all tissue strips were placed into bottle A formalin.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhao Shen Li, M.D · Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-03-26
Completion
2026-08-26

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994611 on ClinicalTrials.gov