Percutaneous Cryoablation Peripheral Lung Cancer

Lung Cancer Clinical Trial

— PCPLC  

Official title:

Percutaneous Cryoablation for the Treatment of Medically Inoperable Peripheral Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02665390
• Other study ID #: SHCHE201601
• Status: Not yet recruiting
• Phase: N/A
• First received: January 22, 2016
• Last updated: February 10, 2016
• Start date: February 2016
• Est. completion date: January 2020

Study information

• Verified date: February 2016
• Source: Shanghai Chest Hospital
• Contact: Sun jiayuan, MD
• Phone: 18017321598
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is focus on percutaneous cryoablation,which was for the treatment of medically inoperable Peripheral lung cancer.The patients who were agreed to attend the study will accept the operation. After the operations,they will follow up according to the plan.

Description:

The patients who were agreed to attend the study conclude early stage lung cancer and solitary metastatic lung cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

medically inoperable peripheral lung cancer Diameter no more than 3cm

Exclusion Criteria:

1. Refusal of participation

2. tendency to bleed to that can't receive percutaneous cryoablation.

3. Severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Percutaneous cryoablation
Percutaneous cryoablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

References & Publications (4)

Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. — View Citation

Yamauchi Y, Izumi Y, Hashimoto K, Yashiro H, Inoue M, Nakatsuka S, Goto T, Anraku M, Ohtsuka T, Kohno M, Kawamura M, Nomori H. Percutaneous cryoablation for the treatment of medically inoperable stage I non-small cell lung cancer. PLoS One. 2012;7(3):e332 — View Citation

Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9. — View Citation

Zhang X, Tian J, Zhao L, Wu B, Kacher DS, Ma X, Liu S, Ren C, Xiao YY. CT-guided conformal cryoablation for peripheral NSCLC: initial experience. Eur J Radiol. 2012 Nov;81(11):3354-62. doi: 10.1016/j.ejrad.2012.04.035. Epub 2012 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		2 years	Yes
Secondary	OS		2 years	Yes