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

NCT04120155 | Completed

• 1 other identifier: IPLP FJUNION
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Apical dead space

  Within 6 months after the operation

• Pleural effusion

  Within 6 months after the operation

• Lung infection

  Within 6 months after the operation

• Atrial fibrillation

  During the postoperative hospital stay

• Operation time

  During the operation

Study Arms (2)

Dissecting the inferior pulmonary ligament

OTHER

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

Procedure: Dissection of the Inferior Pulmonary Ligament

Preserving the inferior pulmonary ligament

OTHER

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

Procedure: Preservation of the Inferior Pulmonary Ligament

Interventions

Dissection of the Inferior Pulmonary Ligament 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.

Dissecting the inferior pulmonary ligament

Preservation of the Inferior Pulmonary Ligament 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.

Preserving the inferior pulmonary ligament

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead
• Fuqing City Hospital: collaborator
• Sanming Second Hospital: collaborator

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Chun Chen, MD

  Fujian Medical University Union Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 9, 2019
• Study Start: March 1, 2020
• Primary Completion: March 15, 2022
• Study Completion: September 30, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

CN (1)