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

NCT06994611 | Not Yet Recruiting

• 1 other identifier: KTSB20250327028
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Keywords

EUS-FNB; solid pancreatic lesion; sample processing; 22D Franseen Needle

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.

  6 months

Secondary Outcomes (3)

• Median puncture number

  2 months

• Tissue adequacy

  2 months

• Puncture time

  2 months

Other Outcomes (2)

• Diagnostic sensitivity

  2 months

• Diagnostic specificity

  2 months

Study Arms (2)

MOSE group

EXPERIMENTAL

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

Procedure: MOSE application

Non-mose group

ACTIVE COMPARATOR

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.

Procedure: Conventional processing

Interventions

MOSE application 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.

MOSE group

Conventional processing PROCEDURE

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

Non-mose group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
• years old (inclusive), male and female;
• patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
• written informed consent was obtained;

You may not qualify if:

• (Before the trial, participants could not be enrolled if they met any of the following requirements)
• contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
• bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
• confirmed pregnancy or possible pregnancy;
• pathological diagnosis has been obtained by other methods;
• refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
• other situations where EUS-FNB could not be performed.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Zhao Shen Li, M.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Yi Ma, M.D

CONTACT

+8613621819595; 504043536@qq.com

Kai Xuan Wang, M.D

CONTACT

wangkaixuan224007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastroenterology, Changhai Hospital

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 29, 2025
• Study Start: June 25, 2025
• Primary Completion: March 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)