NCT04207671

Brief Summary

This study evaluates the viability and safety of two-lumen catheterization versus complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

December 19, 2019

Last Update Submit

January 5, 2020

Conditions

Drainage

Keywords

TubelessWedge resectionImproved drainage strategy

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of massive pneumothorax on day 1 after surgery

    To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray)

    1 day

Secondary Outcomes (3)

  • Pain score on day 1 after surgery

    1 day

  • Length of post-operative hospital stay

    1 week

  • Postoperative pulmonary function recovery

    1 month

Study Arms (2)

Omission of chest tube

OTHER

After wedge resection and the air-leak test, patients will receive complete omission of chest tube and directly close the incision.

Procedure: Complete omission of chest tube

Improved drainage strategy

EXPERIMENTAL

After wedge resection and the air-leak test, patients willreceive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-removal.

Procedure: Improved drainage strategy

Interventions

Complete omission of chest tubePROCEDURE

No chest tube implacement

Omission of chest tube
Improved drainage strategyPROCEDURE

A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove

Improved drainage strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm
  • Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis

You may not qualify if:

  • Previous ipsilateral thoracic surgery or extensive adhesion
  • Preoperative radiology revealed pneumonia or atelectasis
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  • Bleeding tendency or anticoagulant use
  • Pregnancy or breast feeding
  • Patient who can not sign permit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhang JT, Tang YC, Lin JT, Dong S, Nie Q, Jiang BY, Yan HH, Wen ZW, Wu Y, Yang XN, Wu YL, Zhong WZ. Prophylactic air-extraction strategy after thoracoscopic wedge resection. Thorac Cancer. 2018 Nov;9(11):1406-1412. doi: 10.1111/1759-7714.12850. Epub 2018 Sep 6.

    PMID: 30187689BACKGROUND

Study Officials

  • Song Dong

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia-Tao Zhang, Ph.D

CONTACT

+86-83827812-5131118820792959@163.com

Wen-Zhao Zhong, Ph.D

CONTACT

13609777314@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Porfessor

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 23, 2019

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share