Two-Lumen Catheterization For Lung Wedge Resection

Thoracic Surgery, Video-Assisted Clinical Trial

Official title:

Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230019
• Other study ID #: TBL-1
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2018
• Source: Guangdong Provincial People's Hospital
• Contact: Wen-Zhao Zhong
• Phone: 18820792959
• Email: 18820792959[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 30, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• chest tube
VATS with chest tube placement
• two-lumen catheterization
VATS with two-lumen catheterization long the midclavicular line, second intercostal space

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

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Wen-zhao ZHONG	Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Characteristics of plasma exosome for the solitary pulmonary nodules	We prospectively collect the preoperative plasma sample of patients with solitary pulmonary nodule in this study to determine the diagnostic value and molecular characteristics of plasma exosome-derived miRNAs for these patients.	1 month
Primary	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
Primary	Length of post-operative hospital stay	To evaluate the length of post-operative hospital stay	1 week
Primary	Rate of post-operative related complications	To evaluate the rate of post-operative related complications within 7 days of surgery	1 week
Secondary	Postoperative pneumoderm incidence rate	To evaluate the postoperative pneumoderm incidence rate in both groups.	3 days
Secondary	The time of post-operative extubation	To evaluate the time of duration of chest tube or catheterization.	1 week
Secondary	Postoperative pulmonary function recovery	To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.	1 week
Secondary	Postoperative pain score	To evaluate the pain score via NRS pain scale first day after surgery.	1 day
Secondary	Postoperative wound satisfaction	To evaluate the post-operative wound healing condition .	1 month