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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Procedure: Dissection of the Inferior Pulmonary Ligament; Procedure: Preservation of the Inferior Pulmonary Ligament

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dissecting the inferior pulmonary ligament; This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy.	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.
Other: Preserving the inferior pulmonary ligament; This group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Collaborators: Fuqing City Hospital; Sanming Second Hospital
• Investigators: Study Director: Chun Chen, MD, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IPLP FJUNION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No