Back to resultsPreservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy
Primary Purpose
Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dissection of the Inferior Pulmonary Ligament
Preservation of the Inferior Pulmonary Ligament
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases
Eligibility Criteria
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Fujian Medical University Union Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Dissecting the inferior pulmonary ligament
Preserving the inferior pulmonary ligament
Arm Description
This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy.
This group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy.
Outcomes
Primary Outcome Measures
Change in bronchial angle
Change in bronchial angle of each arm(measured by coronal CT)
Change in bronchial angle
Change in bronchial angle of each arm(measured by coronal CT)
Change in lung volume
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
Change in lung volume
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
Secondary Outcome Measures
Apical dead space
Apical dead space incidence rate
Pleural effusion
Pleural effusion incidence rate
Lung infection
Lung infection incidence rate
Atrial fibrillation
Atrial fibrillation incidence rate
Operation time
Operation time
Postoperative hospital stay
Postoperative hospital stay
Closed thoracic drainage tube rentention time
Closed thoracic drainage tube rentention time
Disposable drainage catheter retention time
Disposable drainage catheter retention time
Pathologic cancer stage
Pathologic cancer stage
Histologic diagnosis
Histologic diagnosis
Full Information
NCT ID
NCT04120155
First Posted
September 18, 2019
Last Updated
August 21, 2023
Sponsor
Fujian Medical University Union Hospital
Collaborators
Fuqing City Hospital, Sanming Second Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04120155
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital
Collaborators
Fuqing City Hospital, Sanming Second Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dissecting the inferior pulmonary ligament
Arm Type
Other
Arm Description
This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy.
Arm Title
Preserving the inferior pulmonary ligament
Arm Type
Other
Arm Description
This group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy.
Intervention Type
Procedure
Intervention Name(s)
Dissection of the Inferior Pulmonary Ligament
Intervention Description
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
Intervention Name(s)
Preservation of the Inferior Pulmonary Ligament
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in bronchial angle
Description
Change in bronchial angle of each arm(measured by coronal CT)
Time Frame
3 months after the operation
Title
Change in bronchial angle
Description
Change in bronchial angle of each arm(measured by coronal CT)
Time Frame
6 months after the operation
Title
Change in lung volume
Description
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
Time Frame
3 months after the operation
Title
Change in lung volume
Description
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
Time Frame
6 months after the operation
Secondary Outcome Measure Information:
Title
Apical dead space
Description
Apical dead space incidence rate
Time Frame
Within 6 months after the operation
Title
Pleural effusion
Description
Pleural effusion incidence rate
Time Frame
Within 6 months after the operation
Title
Lung infection
Description
Lung infection incidence rate
Time Frame
Within 6 months after the operation
Title
Atrial fibrillation
Description
Atrial fibrillation incidence rate
Time Frame
During the postoperative hospital stay
Title
Operation time
Description
Operation time
Time Frame
During the operation
Title
Postoperative hospital stay
Description
Postoperative hospital stay
Time Frame
During the postoperative hospital stay
Title
Closed thoracic drainage tube rentention time
Description
Closed thoracic drainage tube rentention time
Time Frame
During the postoperative hospital stay
Title
Disposable drainage catheter retention time
Description
Disposable drainage catheter retention time
Time Frame
Within one month after the operation
Title
Pathologic cancer stage
Description
Pathologic cancer stage
Time Frame
After the operation
Title
Histologic diagnosis
Description
Histologic diagnosis
Time Frame
After the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Chen, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy
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