Skip to main content
OpenTrials
Completed

NCT Number: NCT04120155

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in bronchial angle

    Time frame: 3 months after the operation

    Change in bronchial angle of each arm(measured by coronal CT)

  2. Change in bronchial angle

    Time frame: 6 months after the operation

    Change in bronchial angle of each arm(measured by coronal CT)

  3. Change in lung volume

    Time frame: 3 months after the operation

    Change in lung volume of each arm(measured by Mimics Research 21.0 software)

  4. Change in lung volume

    Time frame: 6 months after the operation

    Change in lung volume of each arm(measured by Mimics Research 21.0 software)

Secondary outcomes

  1. Apical dead space

    Time frame: Within 6 months after the operation

    Apical dead space incidence rate

  2. Pleural effusion

    Time frame: Within 6 months after the operation

    Pleural effusion incidence rate

  3. Lung infection

    Time frame: Within 6 months after the operation

    Lung infection incidence rate

  4. Atrial fibrillation

    Time frame: During the postoperative hospital stay

    Atrial fibrillation incidence rate

  5. Operation time

    Time frame: During the operation

    Operation time

  6. Postoperative hospital stay

    Time frame: During the postoperative hospital stay

    Postoperative hospital stay

  7. Closed thoracic drainage tube rentention time

    Time frame: During the postoperative hospital stay

    Closed thoracic drainage tube rentention time

  8. Disposable drainage catheter retention time

    Time frame: Within one month after the operation

    Disposable drainage catheter retention time

  9. Pathologic cancer stage

    Time frame: After the operation

    Pathologic cancer stage

  10. Histologic diagnosis

    Time frame: After the operation

    Histologic diagnosis

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Collaborators

  • Fuqing City Hospital
  • Sanming Second Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2019
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.