Clinical trial NCT04120155: Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy
Official title: Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy: A Prospective Randomized Controlled Trial（IPLP FJUNION）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
Collaborators: name: Fuqing City Hospital
name: Sanming Second Hospital
First posted: 2019-10-09
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in bronchial angle
timeFrame: 3 months after the operation
measure: Change in bronchial angle
timeFrame: 6 months after the operation
measure: Change in lung volume
timeFrame: 3 months after the operation
measure: Change in lung volume
timeFrame: 6 months after the operation
Secondary outcomes:
measure: Apical dead space
timeFrame: Within 6 months after the operation
measure: Pleural effusion
timeFrame: Within 6 months after the operation
measure: Lung infection
timeFrame: Within 6 months after the operation
measure: Atrial fibrillation
timeFrame: During the postoperative hospital stay
measure: Operation time
timeFrame: During the operation
measure: Postoperative hospital stay
timeFrame: During the postoperative hospital stay
measure: Closed thoracic drainage tube rentention time
timeFrame: During the postoperative hospital stay
measure: Disposable drainage catheter retention time
timeFrame: Within one month after the operation
measure: Pathologic cancer stage
timeFrame: After the operation
measure: Histologic diagnosis
timeFrame: After the operation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chun Chen, MD
role: STUDY_DIRECTOR
References: