Pulmonary Surgical ProceduresPRO-IPLNCT06452680
The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden in Thoracoscopic Pneumonectomy
A study testing Preserving IPL during surgery in people with Pulmonary Surgical Procedures and Patient Reported Outcome Measures, run by Guangdong Provincial People's Hospital at 5 sites in China.
Trial summary
The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Surgical Procedures, Patient Reported Outcome Measures
- What is being tested?
- Preserving IPL during surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- Jun 2024to Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent upper lobe resection
- Patients could complete our questionnaires
Who cannot join
- Previous history of ipsilateral lung surgery
- Patients who underwent pleurodesis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
General Hospital of Southern Theater Command of the Chinese People's Liberation Army
Guangzhou, Guangdong, 510080
Xianglin Li, xwklxl@126.com
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Guibin Qiao, 13602749153, guibinqiao@126.com
Xianglin Li, 18550570726, xwklxl@126.com
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510080
Xianglin Li, xwklxl@126.com
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080
Xianglin Li, xwklxl@126.com
Shantou University Medical College
Shantou, Guangdong, 515041
Xianglin Li, xwklxl@126.com
About this study
Official title: The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy
The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection.
Read the detailed description
Dissection of the inferior pulmonary ligament (IPL) has been a common practice in upper lobectomy to facilitate the expansion of the remaining lung, reduce dead space after resection, and minimize complications such as pleural effusion and pulmonary infection. However, studies have found that IPL dissection does not improve patient outcomes. On the contrary, releasing the restriction may lead to excessive movement of the remaining lobes, resulting in significant changes in bronchial angles and lung volume, which can worsen pulmonary function and increase postoperative symptoms. Most existing studies are retrospective, providing relatively low-level evidence. Moreover, previous research has primarily focused on radiographic outcomes and pulmonary function tests results, while the effect on patients' symptom burden has been largely overlooked. From the patient's perspective, symptom burden might be more significant, reflecting the clinical value of changes in radiographic and functional indices. In this study, the investigators applied patient-reported outcomes to measure symptoms. Combined with pulmonary function results and radiological outcomes, the investigators compared the clinical value of preserving versus dissecting the IPL in upper lobectomy.
- Being tested
- Preserving IPL during surgery
- Keywords
- Inferior pulmonary ligment, Pulmonary Surgical Procedures, Patient Reported Outcome Measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserving IPL during surgeryProcedure or surgery
IPL was preserved during surgery
| Study group | Role | What they receive |
|---|---|---|
| Preservation group | Experimental | In the preservation group, the IPL was untouched Receives: Procedure: Preserving IPL during surgery |
| Dissection group | No intervention | In the dissection group, the IPL was commonly dissected until the inferior pulmonary vein was exposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough score postoperation
The investigators used PSA-LUNG questionnaire to assess patients symptom burden after surgery. Changing of cough score during 1 month postoperation was chosen as the primary outcome.
Measured: up to 3 months
Secondary outcomes (4)
Other Symptom burden postoperation PSA-LUNG questionnaire
Using PSA-LUNG questionnaire, the investigators assessed shortness of breath, pain, sleeplessness, annoy, and fatigue after surgery.
Measured: up to 3 months
Radiological outcome
Changing of bronchial angels measured with chest x-ray examination or chest CT.
Measured: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Radiological outcome
dead spece rate measured with chest x-ray examination or chest CT.
Measured: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Radiological outcome
degree of lung collapse measured with chest x-ray examination or chest CT.
Measured: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuiBin Qiao, Guangdong Provincial People's Hospital
- Investigators
- Guibin Qiao, MD, Study chair, Guangdong Province People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452680
- Sponsor's protocol ID
- KY2023-804-02
- Acronym
- PRO-IPL
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy
- ClinicalTrials.gov ID
- NCT06452680
- Acronym / sponsor ID
- PRO-IPL / KY2023-804-02
- Keywords
- Inferior pulmonary ligment, Pulmonary Surgical Procedures, Patient Reported Outcome Measures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 11 Jun 2024 (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.
The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection.
Detailed description
Dissection of the inferior pulmonary ligament (IPL) has been a common practice in upper lobectomy to facilitate the expansion of the remaining lung, reduce dead space after resection, and minimize complications such as pleural effusion and pulmonary infection. However, studies have found that IPL dissection does not improve patient outcomes. On the contrary, releasing the restriction may lead to excessive movement of the remaining lobes, resulting in significant changes in bronchial angles and lung volume, which can worsen pulmonary function and increase postoperative symptoms. Most existing studies are retrospective, providing relatively low-level evidence. Moreover, previous research has primarily focused on radiographic outcomes and pulmonary function tests results, while the effect on patients' symptom burden has been largely overlooked. From the patient's perspective, symptom burden might be more significant, reflecting the clinical value of changes in radiographic and functional indices. In this study, the investigators applied patient-reported outcomes to measure symptoms. Combined with pulmonary function results and radiological outcomes, the investigators compared the clinical value of preserving versus dissecting the IPL in upper lobectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservation group | Experimental | Procedure: Preserving IPL during surgeryIn the preservation group, the IPL was untouched |
| Dissection group | No intervention | –In the dissection group, the IPL was commonly dissected until the inferior pulmonary vein was exposed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients underwent upper lobe resection
- Patients could complete our questionnaires
Key exclusion criteria (2 listed)
- Previous history of ipsilateral lung surgery
- Patients who underwent pleurodesis
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 |
|---|---|---|
| Preserving IPL during surgeryIPL was preserved during surgery | Procedure or surgery | Preservation group |
Primary outcome
Cough score postoperation
Time frame: up to 3 months
The investigators used PSA-LUNG questionnaire to assess patients symptom burden after surgery. Changing of cough score during 1 month postoperation was chosen as the primary outcome.
4 secondary outcomes
Other Symptom burden postoperation PSA-LUNG questionnaire
Time frame: up to 3 months
Radiological outcome
Time frame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Radiological outcome
Time frame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Radiological outcome
Time frame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
Guibin Qiao, MD study chair
Guangdong Province People's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preserving IPL during surgery in people with Pulmonary Surgical Procedures and Patient Reported Outcome Measures, run by Guangdong Provincial People's Hospital at 5 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guibin Qiao, MD (13602749153, guibinqiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough score postoperation (time frame: up to 3 months). 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 11 Jun 2024.