ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC

NCT04730453 | Unknown DMC

• 1 other identifier: SHCHE202101
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).

Conditions

Lung Cancer

Keywords

Electromagnetic Navigation Bronchoscopy (ENB); Video-Assisted Thoracic Surgery (VATS); Multiple Primary Lung Cancers (MPLC); Ablation Therapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of ablation efficacy, ORR (objective response rate)

  ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST).

  From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.

Secondary Outcomes (3)

• Evaluation of ablation efficacy, PFS (progression-free survival)

  From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

• Evaluation of ablation efficacy, OS (overall survival)

  From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.

• Observation of complications of ablation

  From date of treatment to the one month after ablation.

Interventions

ENB-guided ablation therapy combined with VATS PROCEDURE

After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time.

Eligibility Criteria

• Age: 18 Minutes+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet inclusion/exclusion will be enrolled in the study consecutively.

You may qualify if:

• Age ≥ 18 years old.
• The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
• Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
• The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.

You may not qualify if:

• The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
• The situation in which the investigators think that the subject is not suitable to participate in this study.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (7)

• Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e278S-e313S. doi: 10.1378/chest.12-2359.

  PMID: 23649443 BACKGROUND

• Ambrogi MC, Fanucchi O, Dini P, Melfi F, Davini F, Lucchi M, Massimetti G, Mussi A. Wedge resection and radiofrequency ablation for stage I nonsmall cell lung cancer. Eur Respir J. 2015 Apr;45(4):1089-97. doi: 10.1183/09031936.00188014. Epub 2015 Feb 19.

  PMID: 25700387 BACKGROUND

• Ye X, Fan W, Wang H, Wang J, Wang Z, Gu S, Feng W, Zhuang Y, Liu B, Li X, Li Y, Li C, Xiao Y, Yang P, Yang X, Yang W, Chen J, Zhang R, Lin Z, Meng Z, Hu K, Liu C, Peng Z, Han Y, Jin Y, Lei G, Zhai B, Huang G. Expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors (2018 edition). J Cancer Res Ther. 2018;14(4):730-744. doi: 10.4103/jcrt.JCRT_221_18.

  PMID: 29970646 BACKGROUND

• Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.

  PMID: 27292045 BACKGROUND

• Tsushima K, Koizumi T, Tanabe T, Nakagawa R, Yoshikawa S, Yasuo M, Kubo K. Bronchoscopy-guided radiofrequency ablation as a potential novel therapeutic tool. Eur Respir J. 2007 Jun;29(6):1193-200. doi: 10.1183/09031936.00111306. Epub 2007 Mar 14.

  PMID: 17360727 BACKGROUND

• Tanabe T, Koizumi T, Tsushima K, Ito M, Kanda S, Kobayashi T, Yasuo M, Yamazaki Y, Kubo K, Honda T, Kondo R, Yoshida K. Comparative study of three different catheters for CT imaging-bronchoscopy-guided radiofrequency ablation as a potential and novel interventional therapy for lung cancer. Chest. 2010 Apr;137(4):890-7. doi: 10.1378/chest.09-1065. Epub 2009 Oct 26.

  PMID: 19858232 BACKGROUND

• Xie F, Zheng X, Xiao B, Han B, Herth FJF, Sun J. Navigation Bronchoscopy-Guided Radiofrequency Ablation for Nonsurgical Peripheral Pulmonary Tumors. Respiration. 2017;94(3):293-298. doi: 10.1159/000477764. Epub 2017 Jul 6.

  PMID: 28683443 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

+86-021-22200000; xkyyjysun@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 29, 2021
• Study Start: July 24, 2020
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)