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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04120155
Enrollment
270
Registered
2019-10-09
Start date
2020-03-01
Completion date
2022-09-30
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

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.

Interventions

PROCEDUREDissection 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.

PROCEDUREPreservation 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.

Sponsors

Fuqing City Hospital
CollaboratorUNKNOWN
Sanming Second Hospital
CollaboratorUNKNOWN
Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in bronchial angle3 months after the operationChange in bronchial angle of each arm(measured by coronal CT)
Change in lung volume3 months after the operationChange in lung volume of each arm(measured by Mimics Research 21.0 software)

Secondary

MeasureTime frameDescription
Lung infectionWithin 6 months after the operationLung infection incidence rate
Atrial fibrillationDuring the postoperative hospital stayAtrial fibrillation incidence rate
Operation timeDuring the operationOperation time
Postoperative hospital stayDuring the postoperative hospital stayPostoperative hospital stay
Apical dead spaceWithin 6 months after the operationApical dead space incidence rate
Disposable drainage catheter retention timeWithin one month after the operationDisposable drainage catheter retention time
Pathologic cancer stageAfter the operationPathologic cancer stage
Histologic diagnosisAfter the operationHistologic diagnosis
Closed thoracic drainage tube rentention timeDuring the postoperative hospital stayClosed thoracic drainage tube rentention time
Pleural effusionWithin 6 months after the operationPleural effusion incidence rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026