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NCT Number: NCT06994611

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

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.

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Key information

Conditions

Pancreatic Diseases Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
  • 18-80 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;

Exclusion criteria

  • (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.

Treatment and study plan

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.

Conventional processing

Procedure

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

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 6 months

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

Secondary outcomes

  1. Median puncture number

    Time frame: 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.

  2. Tissue adequacy

    Time frame: 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.

  3. Puncture time

    Time frame: 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.

Other outcomes

  1. Diagnostic sensitivity

    Time frame: 2 months

    Diagnostic sensitivity was calculated as the proportion of true positives in patient cases.

  2. Diagnostic specificity

    Time frame: 2 months

    Diagnostic specificity was calculated as proportion of true negative in healthy cases.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Yi Ma, M.D

CONTACT

[email protected]

+8613621819595

Kai Xuan Wang, M.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Prospective Multicenter Randomized Controlled Non-Inferiority Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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