NCT06052098Recruiting
Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 18 Sept 2023
- Start date
- 11 Oct 2023
- Primary completion date
- Apr 2025
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06052098
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 11 Oct 2023 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation.
Other illness
- Patients with severe pulmonary fibrosis and pulmonary hypertension.
- Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
- Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
- Patients with poorly controlled malignant pleural effusion.
Lab values
- Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
Other
- Eastern Cooperative Oncology Group (ECOG) score \> 2.
- Combined with other tumors with extensive metastasis, expected survival \< 6 months.
- Patients with episodic psychosis.
- Patients with implantable electronic devices (such as pacemaker or defibrillator).
- Pregnant women, or patients who have pregnancy plans during the study.
- Participation or ongoing participation in another clinical study within the past 30 days.
- Other situations that the investigator deems inappropriate to participate in this study.
Who the study is looking for
- Age greater than 18 years.
- Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.