The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden in Thoracoscopic Pneumonectomy (PRO-IPL)

June 10, 2024 updated by: GuiBin Qiao, Guangdong Provincial People's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • General Hospital of Southern Theater Command of the Chinese People's Liberation Army
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • The Affiliated Panyu Central Hospital of Guangzhou Medical University
        • Contact:
      • Shantou, Guangdong, China, 515041
        • Shantou University Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients underwent upper lobe resection
  2. Patients could complete our questionnaires

Exclusion Criteria:

  1. Previous history of ipsilateral lung surgery
  2. Patients who underwent pleurodesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preservation group
In the preservation group, the IPL was untouched
Procedure: Preserving IPL during surgery
IPL was preserved during surgery
No Intervention: Dissection group
In the dissection group, the IPL was commonly dissected until the inferior pulmonary vein was exposed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Symptom burden postoperation PSA-LUNG questionnaire
Time Frame: up to 3 months
Using PSA-LUNG questionnaire, the investigators assessed shortness of breath, pain, sleeplessness, annoy, and fatigue after surgery.
up to 3 months
Radiological outcome
Time Frame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Changing of bronchial angels measured with chest x-ray examination or chest CT.
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
dead spece rate measured with chest x-ray examination or chest CT.
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
degree of lung collapse measured with chest x-ray examination or chest CT.
Day 1 after surgery; 1 month after discharge; 3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Study Chair: Guibin Qiao, MD, Guangdong Province People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY2023-804-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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