RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery (NCT07362342) | Clinical Trial Compass
RecruitingNot Applicable
RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery
Italy100 participantsStarted 2026-01-20
Plain-language summary
Major pulmonary resection is associated with high postoperative morbidity and mortality, mainly due to cardiorespiratory complications. Right ventricular (RV) function is closely related to pulmonary artery pressure and tone, and it is particularly sensitive to changes in afterload. An increase in RV flow resistance can lead to acute RV dilation and reduced left ventricular compliance, potentially progressing to cardiogenic shock. In a previous study (RIVER), it was observed that increased afterload following open thoracic surgery reduces RV function, although this impairment remains subclinical. The aim of this study is to investigate the same parameters in patients with severe cardiovascular comorbidities undergoing pulmonary resection via minimally invasive approaches (VATS and robotic surgery) compared to open thoracotomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged ≥18 years
* Scheduled for elective lobectomy (or bilobectomy) via minimally invasive or open thoracic surgery
* Ability to provide written informed consent at the time of hospital admission
* Moderate to high cardiopulmonary risk, defined by at least one of the following criteria:
* ASA physical status classification 3
* Predicted postoperative FEV1 \<60% and 6-minute walk test \<400 m or cardiopulmonary exercise test \<20 ml/kg/min
* DASI index \<34
* RCRI \>2
* Coronary artery disease
* Heart failure
* Right ventricular systolic dysfunction (TAPSE \<17 mm and/or S' wave on TDI \<10 cm/s)
* Left ventricular systolic dysfunction (EF \<55%)
Exclusion Criteria
* Urgent/emergency surgery
* History of pulmonary embolism
* Previous right or left pneumonectomy
* Previous lobectomy
* Completion pneumonectomy
* Pregnancy (confirmed or suspected)
* History of severe pulmonary hypertension (PAPs \>40 mmHg)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.