Clinical trial NCT03230019: Two-Lumen Catheterization For Lung Wedge Resection
Official title: Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery, Video-Assisted
Keywords: wedge resection
tubeless
Lead sponsor: GuangdongPPH
Sponsor class: UNKNOWN
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2017-07-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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: Postoperative adverse event incidence rate
timeFrame: 1 months
measure: Length of post-operative hospital stay
timeFrame: 1 week
measure: Rate of post-operative related complications
timeFrame: 1 week
Secondary outcomes:
measure: Postoperative pneumoderm incidence rate
timeFrame: 3 days
measure: The time of post-operative extubation
timeFrame: 1 week
measure: Postoperative pulmonary function recovery
timeFrame: 1 week
measure: Postoperative pain score
timeFrame: 1 day
measure: Postoperative wound satisfaction
timeFrame: 1 month
Other outcomes:
measure: Characteristics of plasma exosome for the solitary pulmonary nodules
timeFrame: 1 month
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wen-Zhao Zhong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/j.ejcts.2004.01.041.
citation: 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.
citation: 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.
citation: 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.