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Search / Trial NCT04727190

The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO

Launched by SHANGHAI CHEST HOSPITAL · Jan 24, 2021

Trial Information

Current as of May 08, 2025

Unknown status

Keywords

Lung Ground Glass Opacity Transbronchial Cryobiopsy Forceps Biopsy Diagnosis

ClinConnect Summary

The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Male or female aged between 18 and 80.
  • 2. CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
  • 3. Thin-slice CT scan with bronchial access or adjacent lesions.
  • 4. Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
  • 5. It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
  • 6. Ability to read, understand and sign ICF.
  • Exclusion Criteria:
  • 1. Disseminated GGO, suspected of benign or infectious lesions.
  • 2. Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
  • 3. There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
  • 4. Intolerance or difficulty in cooperating with bronchoscopy, etc.
  • 5. Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
  • 6. Vulnerable groups, such as pregnant women, etc.
  • 7. Some other special situations investigator consider subjects are not suitable to participant in this study.

About Shanghai Chest Hospital

Shanghai Chest Hospital is a leading medical institution in China, renowned for its specialized expertise in respiratory and thoracic diseases. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical research and improving patient outcomes through innovative therapies and treatments. With a strong emphasis on collaboration and scientific rigor, Shanghai Chest Hospital actively engages in a variety of clinical trials aimed at exploring novel interventions and enhancing the understanding of pulmonary health. The hospital's state-of-the-art facilities and commitment to patient-centered care position it as a key player in the global research landscape.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Jiayuan Sun, MD, PhD

Study Director

Shanghai Chest Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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