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

NCT ID: NCT04120155

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-09-30

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.

Conditions

Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dissecting the inferior pulmonary ligament

This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy.

Group Type: OTHER

Dissection of the Inferior Pulmonary Ligament

Intervention Type: PROCEDURE

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.

Preserving the inferior pulmonary ligament

This group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy.

Group Type: OTHER

Preservation of the Inferior Pulmonary Ligament

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuqing City Hospital

UNKNOWN

Sponsor Role: collaborator

Sanming Second Hospital

UNKNOWN

Sponsor Role: collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun Chen, MD

Role: STUDY_DIRECTOR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

IPLP FJUNION

Identifier Type: -

Identifier Source: org_study_id