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Efficacy and safety of pleural forceps biopsy combined with cryobiopsy in the diagnosis of undiagnosed pleural effusion: a multicenter, single-blind, randomized trial

Efficacy and safety of pleural forceps biopsy combined with cryobiopsy in the diagnosis of undiagnosed pleural effusion: a multicenter, single-blind, randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104078
Enrollment
Unknown
Registered
2025-06-10
Start date
2024-06-03
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrothorax

Interventions

Control group:Pleural forceps biopsy alone
Test group:Pleural forceps biopsy combined with cryobiopsy

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Individuals aged >=18 years, both male and female, are eligible; 2.There is pleural effusion that has not been diagnosed after regular examination; 3.There is a need for thoracoscopy in cases with either at least one pleural lesion having a short diameter of >=1 cm, or at least two pleural lesions each having a short diameter of >=0.5 cm; 4.The patient is willing to participate in this study and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Age >= 80 years old; 2.Indoor environment patient pulse oxygen saturation < 88%; 3.Hemodynamic instability; 4.Having had myocardial infarction or unstable angina pectoris within the past 6 weeks; 5.Adhesion-induced absence of pleural space; 6.Having undiagnosed coagulation dysfunction or bleeding tendency; 7.Requiring other open surgery biopsy; 8.Having an active autoimmune disease that requires systemic treatment within the past 2 years, and a history of immuno-deficiency; 9.Positive for HIV antibodies; 10.Currently taking long-term systemic glucocorticoids or other immunosuppressants; 11.Participating in other clinical trials within the past 3 months or participating in another group in this study; 12.Unable to sign the informed consent form; 13.Other circumstances not suitable for participating in this study (such as mental disorder, etc.).

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events;Efficient;

Secondary

MeasureTime frame
Duration of the operation;

Countries

China

Contacts

Public ContactXiong Kunlong

The First Affiliated Hospital of Ningbo University

xiongkl2020@163.com+86 17857295041

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026