Lung DiseasesNCT04120155
Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy
A study testing Dissection of the Inferior Pulmonary Ligament and Preservation of the Inferior Pulmonary Ligament in people with Lung Diseases, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Dissection of the Inferior Pulmonary Ligament and Preservation of the Inferior Pulmonary Ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Diseases
- Being tested
- Dissection of the Inferior Pulmonary Ligament, Preservation of the Inferior Pulmonary Ligament
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissection of the Inferior Pulmonary LigamentProcedure or surgery
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 LigamentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Dissecting the inferior pulmonary ligament | Other | This group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy. Receives: 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. Receives: Procedure: Preservation of the Inferior Pulmonary Ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bronchial angle
Change in bronchial angle of each arm(measured by coronal CT)
Measured: 3 months after the operation
Change in bronchial angle
Change in bronchial angle of each arm(measured by coronal CT)
Measured: 6 months after the operation
Change in lung volume
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
Measured: 3 months after the operation
Change in lung volume
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
Measured: 6 months after the operation
Secondary outcomes (10)
Apical dead space
Apical dead space incidence rate
Measured: Within 6 months after the operation
Pleural effusion
Pleural effusion incidence rate
Measured: Within 6 months after the operation
Lung infection
Lung infection incidence rate
Measured: Within 6 months after the operation
Atrial fibrillation
Atrial fibrillation incidence rate
Measured: During the postoperative hospital stay
Operation time
Operation time
Measured: During the operation
Postoperative hospital stay
Postoperative hospital stay
Measured: During the postoperative hospital stay
Closed thoracic drainage tube rentention time
Closed thoracic drainage tube rentention time
Measured: During the postoperative hospital stay
Disposable drainage catheter retention time
Disposable drainage catheter retention time
Measured: Within one month after the operation
Pathologic cancer stage
Pathologic cancer stage
Measured: After the operation
Histologic diagnosis
Histologic diagnosis
Measured: After the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Mar 2020
- Primary completion15 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fuqing City Hospital, Sanming Second Hospital
- Responsible party
- Sponsor
- Investigators
- Chun Chen, MD, Study director, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120155
- Sponsor's protocol ID
- IPLP FJUNION
- Status last verified
- Aug 2023
- First submitted
- 18 Sep 2019
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy: A Prospective Randomized Controlled Trial（IPLP FJUNION）
- ClinicalTrials.gov ID
- NCT04120155
- Acronym / sponsor ID
- IPLP FJUNION
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- Fuqing City Hospital, Sanming Second Hospital
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dissecting the inferior pulmonary ligament | Other | Procedure: Dissection of the Inferior Pulmonary LigamentThis group of patients will undergo the inferior pulmonary dessection during the upper lobe thoractomy. |
| Preserving the inferior pulmonary ligament | Other | Procedure: Preservation of the Inferior Pulmonary LigamentThis group of patients will undergo the inferior pulmonary preservation during the upper lobe thoractomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dissection of the Inferior Pulmonary LigamentPatients 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. | Procedure or surgery | Dissecting the inferior pulmonary ligament |
| Preservation of the Inferior Pulmonary LigamentPatients 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. | Procedure or surgery | Preserving the inferior pulmonary ligament |
Primary outcome
Change in bronchial angle
Time frame: 3 months after the operation
Change in bronchial angle of each arm(measured by coronal CT)
Change in bronchial angle
Time frame: 6 months after the operation
Change in bronchial angle of each arm(measured by coronal CT)
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)
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)
10 secondary outcomes
Apical dead space
Time frame: Within 6 months after the operation
Pleural effusion
Time frame: Within 6 months after the operation
Lung infection
Time frame: Within 6 months after the operation
Atrial fibrillation
Time frame: During the postoperative hospital stay
Operation time
Time frame: During the operation
Postoperative hospital stay
Time frame: During the postoperative hospital stay
Closed thoracic drainage tube rentention time
Time frame: During the postoperative hospital stay
Disposable drainage catheter retention time
Time frame: Within one month after the operation
Pathologic cancer stage
Time frame: After the operation
Histologic diagnosis
Time frame: After the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Chen, MD study director
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissection of the Inferior Pulmonary Ligament and Preservation of the Inferior Pulmonary Ligament in people with Lung Diseases, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bronchial angle (time frame: 3 months after the operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.