Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy

Not Applicable

Completed

• Conditions: Lung Diseases
• Interventions: Procedure: Dissection of the Inferior Pulmonary Ligament; Procedure: Preservation of the Inferior Pulmonary Ligament

• Registration Number: NCT04120155
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

Many thoracic surgeons tend to dissect the inferior pulmonary ligament (IPL) during upper lobectomy, which in theory reduces the free space in the upper thoracic cavity by increasing the mobility of the residual lung. However, the dissection of IPL may lead to bronchial deformation, stenosis, obstruction or lobe torsion, and distortion. Some studies have found that stenosis might be associated with chronic dry cough and shortness of breath, and could result in a significant decline in lung function. Moreover, the dissection of IPL may lead to greater surgical trauma and increase the incidence of complications. Therefore, this study tries to identify whether we should dissect or preserve the inferior pulmonary ligament during the thoracoscopic upper lobectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2020-03-01
• Primary Completion: 2022-03-15
• Study Completion: 2022-09-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. 18 years old < age < 70 years old;
2. Meet the indications for thoracoscopic left/right upper lobectomy;
3. Gave informed consent and were willing to undergo thoracoscopic left/right upper lobectomy;
4. Preoperative pulmonary function test: FEV1>1L and FEV1>60% of the predicted value;
5. Preoperative ECOG score of 0-1;
6. Preoperative ASA score I-II.

Exclusion Criteria

1. Inferior mediastinal lymphadenopathy was found in preoperative screening;
2. Found that other lobe operations were required at the same time due to multiple lesions in the preoperative discussion;
3. Pregnant or lactating women;
4. Suffering from severe mental illness;
5. History of thoracic surgery (including intrathoracic surgery only, excluding surface surgery such as mastectomy);
6. History of unstable angina or myocardial infarction within the past six months;
7. History of cerebral infarction or cerebral hemorrhage within the past six months;
8. History of continuous systemic corticosteroid therapy within the past month;
9. Abnormal coagulation function, bleeding tendency, or receiving antithrombotic or antiplatelet therapy recently;
10. Suffering from severe liver, kidney, and other systemic diseases;
11. Other situations that are not suitable for surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dissecting the inferior pulmonary ligament	Dissection of the Inferior Pulmonary Ligament	This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy.
Preserving the inferior pulmonary ligament	Preservation of the Inferior Pulmonary Ligament	This group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy.

Primary Outcome Measures

Name	Time	Method
Change in bronchial angle	6 months after the operation	Change in bronchial angle of each arm(measured by coronal CT)
Change in lung volume	6 months after the operation	Change in lung volume of each arm(measured by Mimics Research 21.0 software)

Secondary Outcome Measures

Name	Time	Method
Apical dead space	Within 6 months after the operation	Apical dead space incidence rate
Lung infection	Within 6 months after the operation	Lung infection incidence rate
Closed thoracic drainage tube rentention time	During the postoperative hospital stay	Closed thoracic drainage tube rentention time
Pathologic cancer stage	After the operation	Pathologic cancer stage
Atrial fibrillation	During the postoperative hospital stay	Atrial fibrillation incidence rate
Operation time	During the operation	Operation time
Disposable drainage catheter retention time	Within one month after the operation	Disposable drainage catheter retention time
Pleural effusion	Within 6 months after the operation	Pleural effusion incidence rate
Postoperative hospital stay	During the postoperative hospital stay	Postoperative hospital stay
Histologic diagnosis	After the operation	Histologic diagnosis

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China