Clinical trial NCT02910453: VATS Versus Open Pulmonary Lobectomy in the Limelight of OEP
Official title: VATS Versus Open Pulmonary Lobectomy for Lung Cancer: a Prospective Analysis of Different Impacts on Ribcage Kinematics With Optoelectronic Plethysmography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Pulmonary lobectomy
Video-Assisted Thoracic Surgery
Opto-electronic plethysmography
Posterolateral thoracotomy
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2016-09-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients suitable for pulmonary lobectomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modification of respiratory kinematic
timeFrame: T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References:
citation: LoMauro A, Aliverti A, Chiesa M, Cattaneo M, Privitera E, Tosi D, Nosotti M, Santambrogio L, Palleschi A. Ribcage kinematics during exercise justifies thoracoscopic versus postero-lateral thoracotomy lobectomy prompt recovery. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1197-1205. doi: 10.1093/ejcts/ezx174.