Improved Drainage Strategy for Patients With Lung Wedge Resection

Omission of Chest Tube Versus Improved Drainage Strategy in Patients With Lung Wedge Resection: A Prospective Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: Drainage
• Intervention / Treatment: Procedure: Complete omission of chest tube; Procedure: Improved drainage strategy

Detailed 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% 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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Complete omission of chest tube; No chest tube implacement
Experimental: 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.	Procedure: Improved drainage strategy; A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score on day 1 after surgery	To evaluate the pain score via numerical rating scale on day 1 after surgery. An 11-point numeric scale (NRS 11) with 0 representing no pain and 10 representing worst pain imaginable.	1 day
Length of post-operative hospital stay	To evaluate the length of post-operative hospital stay.	1 week
Postoperative pulmonary function recovery	To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.	1 month

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Song Dong, Guangdong Provincial People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 5, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Tubeless; Wedge resection; Improved drainage strategy
• Other Study ID Numbers: TBL-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No