VATS Versus Open Pulmonary Lobectomy in the Limelight of OEP

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02910453
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function. The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP).

Detailed Description

Rationale: The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function and its relation with chest wall modifications.

Objective: The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic analyzed by optoelectronic plethysmography (OEP).

Study design: A prospective mono-centre single blind trial. Study population: Adult patients of either gender candidate for pulmonary lobectomy for non small cell lung cancer.

Intervention: Patients are submitted to pulmonary lobectomy by video-assisted technique or by postero-lateral thoracotomy. This decision follows the usual clinical evaluations, regardless of whether or not the study enrollment. In particular, they are candidates for postero-lateral thoracotomy if: tumors were close to the hilum or other relevant anatomical structures, or the computed tomography demonstrated hilar calcific lymph-nodes or the lesions were of greater than 4 cm diameter.

Endpoint is evaluation of modification of respiratory kinematic after pulmonary lobectomy, assessed by OEP. In particular, the volume variation of pulmonary rib cage of the treated side versus the relative untreated side and the differences. Respiratory movements and thoracic and abdominal volume changes will be recorded continuously by analyzing the movements of retro-reflective markers using 8 video-cameras connected to an automatic optoelectronic motion analyzer. Subjects are prepared for OEP (markers). Baseline spirometry is take prior to exercise test. All exercise take place on an electromagnetically braked cycle-ergometer. Throughout the protocol heart rate, oxygen saturation and dyspnoea with the Borg scale are recorded. Ventilatory kinematics are monitored throughout exercise using OEP. This OEP analysis involves compartmentalization of the chest into three sections: pulmonary rib cage, abdominal rib cage, and abdomen to determine the contribution of each component to total chest wall volume.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2016-09
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Lesion not in close relation to the hilar structures (bronchus, vessels) based on CT
• Non-Small Cell Lung Cancer clinically staged T1-2, N0 or N1, M0
• Subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate a lobectomy

Exclusion Criteria

• Previous thoracic surgery on same side
• Planned segment resection or pneumonectomy
• Any type of chronic pain, requiring daily use of analgesics
• Body Mass Index (BMI) ≥ 35

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modification of respiratory kinematic	T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery	Compare VATS- over open pulmonary lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP)

Trial Locations

Locations (1)

Fondazione Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy