The Effect of a Combined Drainage Strategy in Uniportal Upper Lung Lobectomy

NCT04461652 | Unknown

• 1 other identifier: TongiU
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional drainage for uniportal video assisted thoracoscopic surgery (VATS) is a routine method, usually with one or two chest tubes at intercostal incisions, but postoperative pain due to the chest tube and unsatisfied drainage effect was noted. In this study, the investigators are going to explore whether a prophylactic air-extraction catheter combined with chest tube drainage may not increase complications in uniportal VATS for upper lung lobectomy. The patients would be assigned to two arms, one with a prophylactic air-extraction catheter combined with chest tube, and another with two chest tubes, and the effect of the combined drainage strategy will be evaluated.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small-Cell Lung Cancer; video-assisted thoracic surgery; drainage tube

Outcome Measures

Primary Outcomes (1)

• pneumothorax incidence

  The incidence of pneumothorax on day 1 after operation

  24-30 hours after surgery

Secondary Outcomes (3)

• pain scores

  1day, 3days and 30 days after surgery

• Extubation time

  within 30 days after surgery

• Total volume

  1 day after surgery

Study Arms (2)

New method

EXPERIMENTAL

One thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle

Procedure: prophylactic air-extraction catheter drainage

Traditional method

PLACEBO COMPARATOR

Two conventional chest tubes (28fr or 24fr) were placed through intercostal incision

Procedure: prophylactic air-extraction catheter drainage

Interventions

prophylactic air-extraction catheter drainage PROCEDURE

This is a kind of venous catheter commonly used in clinic. It may bring less pain after being inserted into the chest, with an equivalent drainage effect with traditional thick drainage tube from our experience, especially in the aspect of gas drainage effect.

New method; Traditional method

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing uniport VATS for left / right upper lobectomy in Shanghai Pulmonary Hospital

You may not qualify if:

• preoperative presence of any unstable systemic disease, such as active infection, uncontrolled hypertension, or unstable angina pectoris;
• previous ipsilateral thoracic surgery;
• preoperative X-ray findings of pneumonia or atelectasis;
• bleeding tendency;
• anticoagulant use;
• pregnancy or breastfeeding;
• converted to open chest;
• the patient underwent pneumonectomy or segmental resection or wedge resection;
• severe adhesion occurred during the operation

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (4)

• Mun M, Nakao M, Matsuura Y, Ichinose J, Nakagawa K, Okumura S. Video-assisted thoracoscopic surgery lobectomy for non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2018 Nov;66(11):626-631. doi: 10.1007/s11748-018-0979-x. Epub 2018 Jul 30.

  PMID: 30062622 RESULT

• Bulgarelli Maqueda L, Garcia-Perez A, Minasyan A, Gonzalez-Rivas D. Uniportal VATS for non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2020 Jul;68(7):707-715. doi: 10.1007/s11748-019-01221-4. Epub 2019 Oct 15.

  PMID: 31617147 RESULT

• Zhang JT, Dong S, Chu XP, Lin SM, Yu RY, Jiang BY, Liao RQ, Nie Q, Yan HH, Yang XN, Wu YL, Zhong WZ. Randomized Trial of an Improved Drainage Strategy Versus Routine Chest Tube After Lung Wedge Resection. Ann Thorac Surg. 2020 Apr;109(4):1040-1046. doi: 10.1016/j.athoracsur.2019.11.029. Epub 2020 Jan 8.

  PMID: 31926158 RESULT

• Liu CY, Hsu PK, Leong KI, Ting CK, Tsou MY. Is tubeless uniportal video-assisted thoracic surgery for pulmonary wedge resection a safe procedure? Eur J Cardiothorac Surg. 2020 Aug 1;58(Suppl_1):i70-i76. doi: 10.1093/ejcts/ezaa061.

  PMID: 32182334 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tao Gui, MD

  Tongji University

  STUDY CHAIR

Central Study Contacts

Xing Wang, MD

CONTACT

+8615901013210; wangxing5447@126.com

Jiang Fan, MD

CONTACT

+86-21-65115006; fan_jiang@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collected from the X-rays and the pain score evaluation will be masked and the outcomes assessor have no method to get randomized information.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The study is a prospective, randomized, non-inferiority trial, two different drainage strategy will be performed, and both were used routinely in clinical practice. One should be one thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle, and another will be two conventional chest tubes (28fr or 24fr) were placed through intercostal incision.

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 8, 2020
• Study Start: January 5, 2020
• Primary Completion: November 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)