Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease

Официальное название

Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial

Обзор

Interstitial lung disease (ILD) often requires histopathological confirmation when high-resolution computed tomography (HRCT) findings are inconclusive. Transbronchial lung cryobiopsy has emerged as a less invasive alternative to surgical lung biopsy, but diagnostic yield remains variable and dependent on biopsy location and procedural precision. Robotic-assisted bronchoscopy (RAB) combined with cone-beam computed tomography (CBCT) may allow more precise navigation to target lung segments and potentially improve biopsy quality and diagnostic yield. This multi-center, investigator-initiated randomized controlled trial will compare conventional bronchoscopy with 2D fluoroscopy guidance versus robotic-assisted bronchoscopy with CBCT guidance for transbronchial lung cryobiopsy in patients undergoing diagnostic evaluation for suspected interstitial lung disease. Participants will be randomized in a 1:1 ratio to undergo either conventional bronchoscopy or robotic-assisted bronchoscopy. In both groups, four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe (en-bloc removal for both study arms). The primary endpoint is the rate of definitive histological diagnosis as determined by a blinded multidisciplinary ILD board.

Подробное описание

Histopathologic evaluation remains a key component in the diagnosis of many interstitial lung diseases when radiological and clinical findings are inconclusive. Transbronchial lung cryobiopsy (TBLC) has increasingly replaced surgical lung biopsy due to its lower morbidity, but diagnostic yield varies widely depending on procedural technique and sampling accuracy.

Robotic-assisted bronchoscopy (RAB) offers improved catheter stability and precise navigation to peripheral lung regions. When combined with cone-beam CT (CBCT), RAB allows real-time confirmation of biopsy location, potentially improving sampling of diagnostically relevant lung parenchyma while avoiding bronchial structures.

However, the incremental diagnostic value of RAB combined with CBCT compared with conventional bronchoscopy using fluoroscopy guidance has not yet been evaluated in a randomized controlled trial.

This investigator-initiated trial aims to determine whether robotic-assisted bronchoscopy with CBCT improves the rate of definitive histological diagnosis compared with conventional bronchoscopy.

Participants will be randomized 1:1 to either:

* Conventional bronchoscopy with fluoroscopy-guided cryobiopsy * Robotic-assisted bronchoscopy with CBCT-guided cryobiopsy

In both arms, four biopsies will be obtained from two different lung lobes using a 1.7 mm cryoprobe.

Histological specimens will be evaluated by a blinded multidisciplinary ILD board.

Вмешательства

• Процедура Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance
  Robotic-assisted bronchoscopy using a shape-sensing robotic platform with cone-beam CT confirmation of biopsy location. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.
• Процедура Conventional Bronchoscopy With Fluoroscopy Guidance
  Flexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.

Первичные конечные точки

• Histological Diagnosis [Срок оценки: Perioperative/Periprocedural]

Вторичные конечные точки (3)

• Biopsy Size [Срок оценки: Perioperative/Periprocedural]
• Tissue Composition of Biopsies [Срок оценки: Perioperative/Periprocedural]
• Safety Composite [Срок оценки: Up to 24 hours post procedure]

Критерии участия

Критерии включения

• Age ≥18 years
• Clinical suspicion of interstitial lung disease requiring histological confirmation
• Non-diagnostic HRCT pattern (e.g. probable UIP or indeterminate pattern)
• Candidate for transbronchial lung cryobiopsy
• Ability to provide informed consent

Критерии исключения

• Definite UIP pattern on HRCT
• Severe pulmonary hypertension
• Severe hypoxemia contraindicating bronchoscopy
• Coagulopathy or contraindication to biopsy
• Pregnancy
• Inability to provide informed consent

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

Простое слепое

Основная цель

Диагностика

Центры проведения

Швейцария · 2 центра

• Cantonal Hospital of Lucerne — Lucerne
• University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT07500818 · BASEC Nr. 2024-00684 Trial B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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