The 22G Franseen Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy

Официальное название

Comparing the Sample Quality of 22G Franseen Needle Combined With Different Aspiration Techniques in Endoscopic Ultrasound-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study

Обзор

The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.

Подробное описание

Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Franseen needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy using a 22G Franseen needle.

Вмешательства

• Процедура ABC
  Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
• Процедура ACB
  Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
• Процедура BAC
  Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
• Процедура BCA
  Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
• Процедура CAB
  Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
• Процедура CBA
  Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.

Первичные конечные точки

• Tissue adequacy [Срок оценки: 2 months]

Вторичные конечные точки (5)

• Cellularity [Срок оценки: 2 months]
• Blood contamination [Срок оценки: 2 months]
• Diagnostic accuracy [Срок оценки: 6 months]
• Diagnostic sensitivity [Срок оценки: 6 months]
• Diagnostic specificity [Срок оценки: 6 months]

Критерии участия

Критерии включения

（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.

Критерии исключения

• 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

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT07023549 · KTSB20250423034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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