Two-Lumen Catheterization For Lung Wedge Resection

NCT ID: NCT03230019

Last Updated: 2018-11-14

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-25

Study Completion Date

2019-10-30

Brief Summary

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This study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, 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\~40% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization for remedial gas-remove. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection.

Conditions

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Thoracic Surgery, Video-Assisted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chest tube

VATS with chest tube placement

Group Type ACTIVE_COMPARATOR

chest tube

Intervention Type PROCEDURE

VATS with chest tube placement

two-lumen catheter

VATS with two-lumen catheterization

Group Type EXPERIMENTAL

two-lumen catheterization

Intervention Type PROCEDURE

VATS with two-lumen catheterization long the midclavicular line, second intercostal space

two-lumen catheter

Intervention Type DEVICE

central venous catheter(two-lumen 7-Fr-20cm)

Interventions

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chest tube

VATS with chest tube placement

Intervention Type PROCEDURE

two-lumen catheterization

VATS with two-lumen catheterization long the midclavicular line, second intercostal space

Intervention Type PROCEDURE

two-lumen catheter

central venous catheter(two-lumen 7-Fr-20cm)

Intervention Type DEVICE

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 collaborator

Wen-zhao ZHONG

UNKNOWN

Sponsor Role lead

Responsible Party

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Wen-zhao ZHONG

Guangdong General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wen-Zhao Zhong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen-Zhao Zhong

Role: CONTACT

18820792959

Song Dong

Role: CONTACT

13631381979

Facility Contacts

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Wen-Zhao Zhong, Ph.D

Role: primary

13609777314

Song Dong, Ph.D

Role: backup

13631381979

References

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Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16.

Reference Type BACKGROUND
PMID: 27865474 (View on PubMed)

Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.

Reference Type BACKGROUND
PMID: 15082297 (View on PubMed)

Ueda K, Hayashi M, Tanaka T, Hamano K. Omitting chest tube drainage after thoracoscopic major lung resection. Eur J Cardiothorac Surg. 2013 Aug;44(2):225-9; discussion 229. doi: 10.1093/ejcts/ezs679. Epub 2013 Jan 12.

Reference Type BACKGROUND
PMID: 23313864 (View on PubMed)

Wei S, Zhang G, Ma J, Nong L, Zhang J, Zhong W, Cui J. Randomized controlled trial of an alternative drainage strategy vs routine chest tube insertion for postoperative pain after thoracoscopic wedge resection. BMC Anesthesiol. 2022 Jan 18;22(1):27. doi: 10.1186/s12871-022-01569-w.

Reference Type DERIVED
PMID: 35042458 (View on PubMed)

Zhang JT, Qin H, Man Cheung FK, Su J, Zhang DD, Liu SY, Li XF, Qin J, Lin JT, Jiang BY, Song Dong, Liao RQ, Qiang N, Yang XN, Tu HY, Zhou Q, Yang JJ, Zhang XC, Zhang YN, Wu YL, Zhong WZ. Plasma extracellular vesicle microRNAs for pulmonary ground-glass nodules. J Extracell Vesicles. 2019 Sep 18;8(1):1663666. doi: 10.1080/20013078.2019.1663666. eCollection 2019.

Reference Type DERIVED
PMID: 31579436 (View on PubMed)

Other Identifiers

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TBL-1

Identifier Type: -

Identifier Source: org_study_id

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