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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.