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Percutaneous Cryoablation Peripheral Lung Cancer (PCPLC)

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous cryoablation
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, Percutaneous cryoablation, treatment of medically inoperable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment

    Arm Description

    Patients who are medically inoperable peripheral lung cancer will enroll in this study.They will receive percutaneous cryoablation and follow-up according to schedule.

    Outcomes

    Primary Outcome Measures

    PFS

    Secondary Outcome Measures

    OS

    Full Information

    First Posted
    January 22, 2016
    Last Updated
    February 10, 2016
    Sponsor
    Shanghai Chest Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02665390
    Brief Title
    Percutaneous Cryoablation Peripheral Lung Cancer
    Acronym
    PCPLC
    Official Title
    Percutaneous Cryoablation for the Treatment of Medically Inoperable Peripheral Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Chest Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    lung cancer, Percutaneous cryoablation, treatment of medically inoperable

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment
    Arm Type
    Experimental
    Arm Description
    Patients who are medically inoperable peripheral lung cancer will enroll in this study.They will receive percutaneous cryoablation and follow-up according to schedule.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous cryoablation
    Intervention Description
    Percutaneous cryoablation
    Primary Outcome Measure Information:
    Title
    PFS
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    OS
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: medically inoperable peripheral lung cancer Diameter no more than 3cm Exclusion Criteria: Refusal of participation tendency to bleed to that can't receive percutaneous cryoablation. Severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sun jiayuan, MD
    Phone
    18017321598
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sun jiayuan, MD
    Organizational Affiliation
    Shanghai Chest Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22626572
    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.
    Results Reference
    background
    PubMed Identifier
    16678583
    Citation
    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. doi: 10.1016/j.jtcvs.2005.12.051.
    Results Reference
    background
    PubMed Identifier
    22096520
    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.
    Results Reference
    background
    PubMed Identifier
    22413004
    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):e33223. doi: 10.1371/journal.pone.0033223. Epub 2012 Mar 8.
    Results Reference
    result

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    Percutaneous Cryoablation Peripheral Lung Cancer

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