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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Pulmonary Surgical Procedures; Patient Reported Outcome Measures

Treatments: Procedure: Preserving IPL during surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06452680

KY2023-804-02

Details and patient eligibility

About

The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Preservation group

Experimental group

Description:

In the preservation group, the IPL was untouched

Treatment:

Procedure: Preserving IPL during surgery

Dissection group

No Intervention group

Description:

In the dissection group, the IPL was commonly dissected until the inferior pulmonary vein was exposed