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Идёт набор NCT06741839

Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease

Без фазы С лечением Pleural Diseases Pleural Effusion

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy, Plerual biopsy using medical thoracoscopy.
Кому может быть актуально
Состояния в реестре: Pleural Diseases, Pleural Effusion. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial

Обзор

A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.

Вмешательства

  • Процедура Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy
    After the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE.
  • Процедура Plerual biopsy using medical thoracoscopy
    After the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps.

Первичные конечные точки

  • Diagnostic yield [Срок оценки: Up to 12 months after the procedure]
Вторичные конечные точки (6)
  • Negative likelihood ratio [Срок оценки: Up to 12 months after the procedure]
  • Diagnostic sensitivity for specific diseases [Срок оценки: Up to 12 months after the procedure]
  • Procedural time [Срок оценки: Day of procedure]
  • Rate of adequate specimens for achieving molecular diagnosis [Срок оценки: Within 2 weeks after the procedure (upon pathological reporting)]
  • Incidence of procedure-related complications [Срок оценки: From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer)]
  • Sampling quality (tissue depth and interpretability) [Срок оценки: Within 2 weeks after the procedure (upon pathological assessment)]

Критерии участия

Критерии включения

  • Age ≥ 18 years;
  • Evidence of exudative pleural effusion in which a specific diagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations
  • Willingness to participate in the study and undergo an invasive procedure.;

Критерии исключения

  • Pleural thickening or pleural-based mass without pleural effusion on radiologic examination;
  • Hemodynamic instability;
  • Presence of parapneumonic effusion;
  • Any contraindication to pleural biopsy or semirigid thoracoscopy;
  • Participation in other studies within three months without withdrawal or termination.

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

  • Deng MM, Hu Y, Liu X, Feng Y, Zheng Z, Tong R, Porcel J, Hou G. Diagnostic yield and safety of probe-based confocal laser endomicroscopy-guided pleural biopsy via semirigid thoracoscope in diagnosing patients with unknown pleural effusion: a protocol for a multicentre, randomised controlled trial (COLLABORATION-I). BMJ Open. 2026 Jun 4;16(6):e117208. doi: 10.1136/bmjopen-2026-117208. PMID 42242740

Идентификаторы

NCT: NCT06741839 · 2022YFC2404404-3-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗