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

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Diseases

• Registration Number: NCT06994611
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study Start: 2025-05-25
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2026-03-26
• Study Completion: 2026-08-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	6 months	Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.

Secondary Outcome Measures

Name	Time	Method
Median puncture number	2 months	In the MOSE group, if the MVC of the first needle sample was ≥10mm, an additional needle was inserted. If the MVC of the first stitch is \< 10mm, continue to puncture until the total length of the MVC of the sample is ≥10mm. In the non-MOSE group, fixed puncture was performed with 2 needles.
Tissue adequacy	2 months	Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.
Puncture time	2 months	The puncture time of the MOSE group was defined as the beginning of puncture to the end of the confirmation of sufficient MOSE, and the puncture time of the non-MOSE group was defined as the beginning of puncture to the end of 2 stitches.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China