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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120155
• Other study ID #: IPLP FJUNION
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2023
• Source: Fujian Medical University Union Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 30, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Procedure:
• Dissection of the Inferior Pulmonary Ligament
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.
• Preservation of the Inferior Pulmonary Ligament
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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital	Fuqing City Hospital, Sanming Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bronchial angle	Change in bronchial angle of each arm(measured by coronal CT)	3 months after the operation
Primary	Change in bronchial angle	Change in bronchial angle of each arm(measured by coronal CT)	6 months after the operation
Primary	Change in lung volume	Change in lung volume of each arm(measured by Mimics Research 21.0 software)	3 months after the operation
Primary	Change in lung volume	Change in lung volume of each arm(measured by Mimics Research 21.0 software)	6 months after the operation
Secondary	Apical dead space	Apical dead space incidence rate	Within 6 months after the operation
Secondary	Pleural effusion	Pleural effusion incidence rate	Within 6 months after the operation
Secondary	Lung infection	Lung infection incidence rate	Within 6 months after the operation
Secondary	Atrial fibrillation	Atrial fibrillation incidence rate	During the postoperative hospital stay
Secondary	Operation time	Operation time	During the operation
Secondary	Postoperative hospital stay	Postoperative hospital stay	During the postoperative hospital stay
Secondary	Closed thoracic drainage tube rentention time	Closed thoracic drainage tube rentention time	During the postoperative hospital stay
Secondary	Disposable drainage catheter retention time	Disposable drainage catheter retention time	Within one month after the operation
Secondary	Pathologic cancer stage	Pathologic cancer stage	After the operation
Secondary	Histologic diagnosis	Histologic diagnosis	After the operation