Clinical trial NCT04207671: Improved Drainage Strategy for Patients With Lung Wedge Resection
Official title: Omission of Chest Tube Versus Improved Drainage Strategy in Patients With Lung Wedge Resection: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drainage
Keywords: Tubeless
Wedge resection
Improved drainage strategy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence rate of massive pneumothorax on day 1 after surgery
timeFrame: 1 day
Secondary outcomes:
measure: Pain score on day 1 after surgery
timeFrame: 1 day
measure: Length of post-operative hospital stay
timeFrame: 1 week
measure: Postoperative pulmonary function recovery
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Song Dong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.