Two-Lumen Catheterization For Lung Wedge Resection
Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial
1 other identifier
interventional
96
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2017
CompletedFirst Posted
Study publicly available on registry
July 26, 2017
CompletedStudy Start
First participant enrolled
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedNovember 14, 2018
November 1, 2018
2.1 years
July 23, 2017
November 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Postoperative adverse event incidence rate
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (\>800ml) in both groups.
1 months
Length of post-operative hospital stay
To evaluate the length of post-operative hospital stay
1 week
Rate of post-operative related complications
To evaluate the rate of post-operative related complications within 7 days of surgery
1 week
Secondary Outcomes (5)
Postoperative pneumoderm incidence rate
3 days
The time of post-operative extubation
1 week
Postoperative pulmonary function recovery
1 week
Postoperative pain score
1 day
Postoperative wound satisfaction
1 month
Other Outcomes (1)
Characteristics of plasma exosome for the solitary pulmonary nodules
1 month
Study Arms (2)
chest tube
ACTIVE COMPARATORVATS with chest tube placement
two-lumen catheter
EXPERIMENTALVATS with two-lumen catheterization
Interventions
VATS with two-lumen catheterization long the midclavicular line, second intercostal space
Eligibility Criteria
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
- Wen-zhao ZHONGlead
- Guangdong Provincial People's Hospitalcollaborator
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 51000, China
Related Publications (5)
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.
PMID: 27865474BACKGROUNDWatanabe 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.
PMID: 15082297BACKGROUNDUeda 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.
PMID: 23313864BACKGROUNDWei 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.
PMID: 35042458DERIVEDZhang 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.
PMID: 31579436DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Zhao Zhong, Ph.D
Guangdong Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Guangdong General Hospital
Study Record Dates
First Submitted
July 23, 2017
First Posted
July 26, 2017
Study Start
August 25, 2017
Primary Completion
October 1, 2019
Study Completion
October 30, 2019
Last Updated
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share