A randomized trial comparing the duration of procedure using rigid mini-thoracoscopy and semirigid thoracoscopy in undiagnosed or malignant pleural effusion

Rigid Mini-Thoracoscopy Versus Semirigid Pleuroscopy in Undiagnosed Exudative and Suspected Malignant Pleural Effusion: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260508007

Enrollment

Registered

2026-05-08

Start date

2021-10-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Undiagnosed exudative pleural effusion or suspected malignant pleural effusion Undiagnosed pleural effusion Malignant pleural effusion Rigid mini-thoracoscope Semirigid pleuroscope Pleural biopsy Pleurodesis

Interventions

Rigid mini-thoracoscope (Richard Wolf GmbH, Knittlingen, Germany) had an outer diameter of 5.5 mm, a working length of 215 mm, a 3.5-mm working channel, and was used with rigid 3.5-mm cup biopsy force

Olympus Corp., Tokyo, Japan) had an outer diameter of 7 mm, a working length of 270 mm, a 2.8-mm working channel, and angulation of 160 degree upward and 130 degree downward, and was used with the man

s flexible biopsy forceps. Talc poudrage was perform via the flexible catheter inserting through a working channel. After complete spraying sterile talc, chest drain 20F, was placed and then applied t

Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery

Rigid mini-thoracoscope ,Semirigid pleuroscope

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults, age over 18 years old 2. Unilateral or bilateral undiagnosed exudative pleural effusion or strongly suspected of having malignant pleural effusion. 3. Effusion amount, depth on upright chest radiograph had to exceed 2 cm at the mid-hemithorax to ensure a safe working space.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Uncorrectable coagulopathy or thrombocytopenia 3. Hemodynamic instability 4. Refractory hypoxemia (saturation less than 90% on supplemental oxygen)

Design outcomes

Primary

Measure	Time frame
Total procedure duration immediate after procedure minutes	—

Secondary

Measure	Time frame
Pleural biopsy specimen size immediate after procedure square millimeter,Diagnostic yield about 2 weeks (waiting for final pathological report) percentage,Pleurodesis success 6, 12 weeks after procedure percentage,Intraoperative Pain Score 2 hours after procedure Visual analogue scale, 0-10,Procedure related complication within 12 weeks after procedure incidences	—

Countries

Thailand

Contacts

Public ContactVorawut Thanthitaweewat

Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

v.thanthitaweewat@gmail.com0897638538

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026