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NCT06994611

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

Not yet recruiting NA Last updated 6 June 2025
What this trial tests

NA trial testing MOSE application in Pancreatic Diseases in 148 participants. Not yet recruiting.

Timeline
25 June 2025
Primary endpoint
26 March 2026
26 August 2026

Quick facts

Lead sponsorChanghai Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposediagnostic
Enrollment148
Start date25 June 2025
Primary completion26 March 2026
Estimated completion26 August 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Changhai Hospital

Who can join

Adults 18 to 80, any sex, with Pancreatic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pancreatic Diseases

Currently open trials in the same condition.

Other Changhai Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06994611.

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