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

Study Overview
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Brief Summary
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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.

Official Title
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Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy: A Prospective Randomized Controlled Trial（IPLP FJUNION）

Conditions
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Lung Diseases

Intervention / Treatment
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* Procedure: Dissection of the Inferior Pulmonary Ligament
* Procedure: Preservation of the Inferior Pulmonary Ligament


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old < age < 70 years old; Meet the indications for thoracoscopic left/right upper lobectomy; Gave informed consent and were willing to undergo thoracoscopic left/right upper lobectomy; Preoperative pulmonary function test: FEV1>1L and FEV1>60% of the predicted value; Preoperative ECOG score of 0-1; Preoperative ASA score I-II. Exclusion Criteria: Inferior mediastinal lymphadenopathy was found in preoperative screening; Found that other lobe operations were required at the same time due to multiple lesions in the preoperative discussion; Pregnant or lactating women; Suffering from severe mental illness; History of thoracic surgery (including intrathoracic surgery only, excluding surface surgery such as mastectomy); History of unstable angina or myocardial infarction within the past six months; History of cerebral infarction or cerebral hemorrhage within the past six months; History of continuous systemic corticosteroid therapy within the past month; Abnormal coagulation function, bleeding tendency, or receiving antithrombotic or antiplatelet therapy recently; Suffering from severe liver, kidney, and other systemic diseases; Other situations that are not suitable for surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dissecting the inferior pulmonary ligament<br>This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy. | Procedure: Dissection of the Inferior Pulmonary Ligament<br>* Patients will be categorized into two groups: the division group ,who will receive the division of the inferior pulmonary ligament, and the preservation group, who will not.For the dissection group, we will dissect the inferior pulmonary ligament during the surgery.<br>|
| Other: Preserving the inferior pulmonary ligament<br>This group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy. | Procedure: Preservation of the Inferior Pulmonary Ligament<br>* Patients will be categorized into two groups: the division group ,who will receive the division of the inferior pulmonary ligament, and the preservation group, who will not.For the preservation group, we will preserve the inferior pulmonay ligament during the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bronchial angle | Change in bronchial angle of each arm(measured by coronal CT) | 3 months after the operation | 
| Change in bronchial angle | Change in bronchial angle of each arm(measured by coronal CT) | 6 months after the operation | 
| Change in lung volume | Change in lung volume of each arm(measured by Mimics Research 21.0 software) | 3 months after the operation | 
| Change in lung volume | Change in lung volume of each arm(measured by Mimics Research 21.0 software) | 6 months after the operation | 

Secondary Outcome Measures

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