Two-Lumen Catheterization For Lung Wedge Resection

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

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.

Study Overview

• Status: Unknown
• Conditions: Thoracic Surgery, Video-Assisted
• Intervention / Treatment: Procedure: chest tube; Procedure: two-lumen catheterization; Device: two-lumen catheter

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 10~40% 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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 51000
      • Recruiting
      • Guangdong General Hospital
      • Contact: Wen-Zhao Zhong, Ph.D; Phone Number: 13609777314; Email: 13609777314@163.com
      • Contact: Song Dong, Ph.D; Phone Number: 13631381979; Email: dsong@aliyun.com

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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: chest tube; VATS with chest tube placement	Procedure: chest tube; VATS with chest tube placement
Experimental: two-lumen catheter; VATS with two-lumen catheterization	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pneumoderm incidence rate	To evaluate the postoperative pneumoderm incidence rate in both groups.	3 days
The time of post-operative extubation	To evaluate the time of duration of chest tube or catheterization.	1 week
Postoperative pulmonary function recovery	To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.	1 week
Postoperative pain score	To evaluate the pain score via NRS pain scale first day after surgery.	1 day
Postoperative wound satisfaction	To evaluate the post-operative wound healing condition .	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wen-zhao ZHONG
• Collaborators: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Wen-Zhao Zhong, Ph.D, Guangdong Provincial People's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 23, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 10, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: wedge resection; tubeless
• Other Study ID Numbers: TBL-1

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