Right Ventricle Response After Major Lung Resection with Minimally Invasive or Open Surgery
Official title: RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery (the RIVER-2 Study)
Run by Istituto Clinico Humanitas · NCT07362342 · Data updated 2026-11-12
This study tests how the right side of the heart handles increased pressure after major lung surgery in patients with heart or lung risks, comparing minimally invasive procedures to open surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, MI) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07362342 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with moderate to high cardiopulmonary risk undergoing elective lobectomy or bilobectomy by either minimally invasive or open thoracic approach.
✕Probably not a fit
Patients without significant cardiopulmonary risk or those not experiencing changes in RV afterload may not derive specific benefits from this observational study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines how the right ventricle functions after major lung resection in adults with cardiovascular or pulmonary risk factors, comparing outcomes between minimally invasive approaches (VATS or robotic) and open thoracotomy. Researchers will look at changes in right heart loading and performance related to lung resection and surgical approach. The study builds on prior findings that increased afterload can affect RV function, even if early signs are subclinical. Data will be collected from patients undergoing lobectomy or bilobectomy and will consider preoperative risk, intraoperative factors, and postoperative RV performance. No specific intervention is being tested beyond observing natural variations by surgical method.
Why it matters
Potential benefit: If successful, findings could improve understanding of RV risk after lung surgery and guide perioperative management to reduce complications.
How similar studies have gone: Prior observations in open surgery suggested subclinical RV impairment with increased afterload; this study extends to minimally invasive approaches and is exploratory in context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Humanitas Research Hospital
Rozzano, Mi, Italy Recruiting
Study contacts
- Study coordinator: Enrico Giustiniano EG Doctor, Anesthesiologist
- Email: enrico.giustiniano@humanitas.it
- Phone: 0288247459
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.