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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура Conventional processing
  Two needles were punctured and all tissue strips were placed into bottle A formalin.

Первичные конечные точки

• Diagnostic accuracy [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Median puncture number [Срок оценки: 2 months]
• Tissue adequacy [Срок оценки: 2 months]
• Puncture time [Срок оценки: 2 months]

Критерии участия

Критерии включения

• (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;

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT06994611 · KTSB20250327028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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