Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion

Обзор

Brief Summary The goal of this clinical trial is to determine whether an initial diagnostic approach using ultrasound elastography-guided pleural biopsy (UEPB) is non-inferior to immediate medical thoracoscopic pleural biopsy in terms of diagnostic yield for obtaining a definitive histopathological diagnosis in patients with exudative pleural effusion of unclear etiology. The main questions it aims to answer are: Is the step-up strategy (UEPB first, reserving thoracoscopy for non-diagnostic cases) non-inferior to immediate medical thoracoscopy in diagnostic yield? Does the step-up strategy provide advantages in safety, patient tolerance, hospital stay, and cost-effectiveness compared to immediate thoracoscopy? Researchers will compare a step-up strategy (initial UEPB, followed by medical thoracoscopy if UEPB is non-diagnostic) versus immediate medical thoracoscopic pleural biopsy to see if the step-up approach achieves comparable diagnostic accuracy while potentially reducing procedure-related burden and healthcare resource use. Participants will: Be randomly assigned in a 1:1 ratio to either the step-up strategy arm or the immediate medical thoracoscopy arm. If assigned to the step-up arm: undergo UEPB under local anesthesia; if the biopsy is non-diagnostic, proceed to semi-rigid medical thoracoscopy. If assigned to the immediate thoracoscopy arm: undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. Provide tissue samples for histopathological, immunohistochemical, and molecular analyses as clinically indicated. Complete short-term follow-up at 7 days post-procedure (by telephone or clinic visit) to monitor adverse events and symptom recovery. If initially diagnosed with non-specific benign disease or remain undiagnosed, complete a long-term follow-up at 12 months to establish a final diagnosis.

Вмешательства

• Процедура Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy
  Participants receive ultrasound elastography-guided pleural biopsy (UEPB) as the first diagnostic procedure. If the UEPB specimen is non-diagnostic, participants proceed to semi-rigid medical thoracoscopic pleural biopsy.
• Процедура Semi-rigid thoracoscopic pleural biopsy
  Participants receive semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. The procedure is performed under local anaesthesia or moderate sedation, with biopsies obtained under direct visualization. A chest tube is inserted prophylactically following biopsy; chemical pleurodesis may be performed during the same procedure if clinically indicated.

Первичные конечные точки

• Diagnostic yield [Срок оценки: 7 days after the procedure]

Вторичные конечные точки (4)

• diagnostic sensitivity [Срок оценки: 7 days after procedure]
• Diagnostic specificity [Срок оценки: 7 days after procedure]
• The avoidance of semi-rigid thoracoscopy [Срок оценки: 7 days after the procedure]
• The rate of unexpected chest tube drainage [Срок оценки: 7 days after procedure]

Критерии участия

Критерии включения

• Age ≥18 years;
• Patients with exudative pleural effusion of unknown origin;
• Patients with negative pleural fluid cytology results;
• Patients who had not undergone pleural biopsy before enrolment.

Критерии исключения

• Significantly bleeding risk, including uncorrectable coagulopathy (such as INR >1.5, platelet count <50×109 /L) or the need for ongoing anticoagulant/antiplatelet therapy that cannot be safely paused;
• Hemodynamic instability;
• Refractory hypoxemia despite supplemental oxygen;
• Any severe concurrent illness or cardiopulmonary compromise that, in the investigator's judgment, makes either procedural sedation (for thoracoscopy) or a bedside biopsy (for UEPB) unsafe;
• Pleural effusion conclusively identified as a transudate;
• Pregnancy or lactation;
• Any condition that, in the investigator's judgment, would compromise protocol compliance or follow-up.

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

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Публикации

• Liao L, Ma J, Ni J, Lin J, Zhao S, Xia Y, Liu X, Deng M, Zheng Z, Hou G. Ultrasonic elastography-guided pleural biopsy followed by as-needed semi-rigid thoracoscopic pleural biopsy versus immediate semi-rigid thoracoscopic pleural biopsy for the diagnosis of pleural effusion (UPDATE-3): a protocol of randomised controlled trial. Respir Res. 2026 Jun 20. doi: 10.1186/s12931-026-03772-6. Online ahea PMID 42321816

Идентификаторы

NCT: NCT07419620 · UPDATE-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗