Improved Drainage Strategy for Patients With Lung Wedge Resection

NCT ID: NCT04207671

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades. The concept of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest tube placement. Chest tube placement always causes pain, and its duration is known to be one of the most important factors influencing hospital stay and costs. Early tube removal allows patients to breathe deeply with less pain, which leads to more compliance with chest physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory function. Hence, more and more experienced surgeons choose the omission of chest tube placement after lung wedge resection. However, based on previous retrospective studies, residual pneumothorax was noted in about 10% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization as improved drainage strategy. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus omission of chest tube placement in patients with lung wedge resection.

Conditions

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Drainage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Omission of chest tube

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

Group Type OTHER

Complete omission of chest tube

Intervention Type PROCEDURE

No chest tube implacement

Improved drainage strategy

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.

Group Type EXPERIMENTAL

Improved drainage strategy

Intervention Type PROCEDURE

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

Interventions

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Complete omission of chest tube

No chest tube implacement

Intervention Type PROCEDURE

Improved drainage strategy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Previous ipsilateral thoracic surgery or extensive adhesion
2. Preoperative radiology revealed pneumonia or atelectasis
3. 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).
4. Bleeding tendency or anticoagulant use
5. Pregnancy or breast feeding
6. Patient who can not sign permit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-zhao ZHONG

Porfessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Song Dong

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Central Contacts

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Jia-Tao Zhang, Ph.D

Role: CONTACT

+86-83827812-51311

Wen-Zhao Zhong, Ph.D

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 30187689 (View on PubMed)

Other Identifiers

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TBL-2

Identifier Type: -

Identifier Source: org_study_id

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