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

NCT ID: NCT06994611

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2026-08-26

Brief 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

Pancreatic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

MOSE group

Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation

Group Type: EXPERIMENTAL

MOSE application

Intervention Type: PROCEDURE

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.

Non-mose group

Patients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin.

Group Type: ACTIVE_COMPARATOR

Conventional processing

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Conventional processing

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)

1. 18-80 years old (inclusive), male and female;

2. patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.

3. written informed consent was obtained;

Exclusion Criteria

• (Before the trial, participants could not be enrolled if they met any of the following requirements)

1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;

2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;

3. confirmed pregnancy or possible pregnancy;

4. pathological diagnosis has been obtained by other methods;

5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.

6. other situations where EUS-FNB could not be performed.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

Department of Gastroenterology, Changhai Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Shen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China

Locations

Changhai Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jia Yi Ma, M.D

Role: CONTACT

504043536@qq.com

+8613621819595

Kai Xuan Wang, M.D

Role: CONTACT

wangkaixuan224007@163.com

Other Identifiers

KTSB20250327028

Identifier Type: -

Identifier Source: org_study_id