Lung SurgeryRIVER-2NCT07362342
RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery
An observational study of Lung Surgery and Right Ventricular Function, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Surgery, Right Ventricular Function
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective observational study in patients undergoing elective major thoracic surgery.
Who may be able to join
- 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
Show all 12Show fewer
- 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%)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, MI, 20089
About this study
Official title: RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery (the RIVER-2 Study)
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.
Read the detailed description
- Major lung resection is associated with high postoperative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications. An overall cardiovascular performance assessment is usually carried out before this type of surgery, along with pulmonary function tests. In such a context, close attention to the right ventricle (RV) function is recommended.
- The RV is known to be exquisitely sensitive to changes in afterload. Since RV ejection, pulmonary artery pressure (PAP), and tone are tightly coupled, an impairment in pulmonary vascular reserve can compromise RV ejection, increasing right atrial pressure and limiting maximal cardiac output. We know that during acute massive pulmonary embolism (PE), the acute increase in RV outflow resistance causes acute RV dilatation and, using ventricular interdependence, markedly decreased left ventricle (LV) compliance, rapidly spiraling to acute cardiogenic shock and death. We want to explore if during major lung surgery such maneuvers as pulmonary artery branch clamping could bring to the same event. Furthermore, a postoperative RV disfunction (RVD) has been observed after open major lung surgery; in our previous study we showed that the observed increase in afterload reduced the post-operative RV function after open surgery (thoracotomy), but the impairment remained subclinical, with the RV failure being rarely observed.
- More in general, this effect has been investigated in literature and all studies agree with the conclusion that the postoperative RV disfunction is common after major lung surgery but there is no evidence of acute cardiogenic shock, neither during clamping nor in the port-operative period, suggesting that the mechanisms involved in the RV response are various (not just RV resistances) and, to date, not well defined. Little is known on RV disfunction after video-assisted thoracoscopic surgery.
- With this study our aim is to observe the difference in RV disfunction after mini-invasive video-assisted thoracic surgery (VATS and robotic surgery) compared to the open surgical approach, in the hypothesis that the thoracic compliance plays an important role in the cardio-pulmonary balance and it could be more impaired during open surgery.
RATIONALE To understand whether and to what extent RV dysfunction occurs after surgery in patients undergoing mini-invasive thoracic surgery and to compare RV function alterations after mini-invasive thoracic surgery to the open apporach.
- Conditions
- Lung Surgery, Right Ventricular Function
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic Measurement of RV dysfunction
Measurement of TAPSE and/or S' wave using Tissue Doppler Imaging (TDI); TAPSE/PAPs ratio
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start20 Jan 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362342
- Sponsor's protocol ID
- 4590
- Acronym
- RIVER-2
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery (the RIVER-2 Study)
- ClinicalTrials.gov ID
- NCT07362342
- Acronym / sponsor ID
- RIVER-2 / 4590
- Conditions
- Lung Surgery, Right Ventricular Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Major lung resection is associated with high postoperative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications. An overall cardiovascular performance assessment is usually carried out before this type of surgery, along with pulmonary function tests. In such a context, close attention to the right ventricle (RV) function is recommended.
- The RV is known to be exquisitely sensitive to changes in afterload. Since RV ejection, pulmonary artery pressure (PAP), and tone are tightly coupled, an impairment in pulmonary vascular reserve can compromise RV ejection, increasing right atrial pressure and limiting maximal cardiac output. We know that during acute massive pulmonary embolism (PE), the acute increase in RV outflow resistance causes acute RV dilatation and, using ventricular interdependence, markedly decreased left ventricle (LV) compliance, rapidly spiraling to acute cardiogenic shock and death. We want to explore if during major lung surgery such maneuvers as pulmonary artery branch clamping could bring to the same event. Furthermore, a postoperative RV disfunction (RVD) has been observed after open major lung surgery; in our previous study we showed that the observed increase in afterload reduced the post-operative RV function after open surgery (thoracotomy), but the impairment remained subclinical, with the RV failure being rarely observed.
- More in general, this effect has been investigated in literature and all studies agree with the conclusion that the postoperative RV disfunction is common after major lung surgery but there is no evidence of acute cardiogenic shock, neither during clamping nor in the port-operative period, suggesting that the mechanisms involved in the RV response are various (not just RV resistances) and, to date, not well defined. Little is known on RV disfunction after video-assisted thoracoscopic surgery.
- With this study our aim is to observe the difference in RV disfunction after mini-invasive video-assisted thoracic surgery (VATS and robotic surgery) compared to the open surgical approach, in the hypothesis that the thoracic compliance plays an important role in the cardio-pulmonary balance and it could be more impaired during open surgery.
RATIONALE To understand whether and to what extent RV dysfunction occurs after surgery in patients undergoing mini-invasive thoracic surgery and to compare RV function alterations after mini-invasive thoracic surgery to the open apporach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective observational study in patients undergoing elective major thoracic surgery.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- Urgent/emergency surgery
- History of pulmonary embolism
- Previous right or left pneumonectomy
- Previous lobectomy
- Completion pneumonectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Echocardiographic Measurement of RV dysfunction
Time frame: 1 year
Measurement of TAPSE and/or S' wave using Tissue Doppler Imaging (TDI); TAPSE/PAPs ratio
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Related trials for Lung Surgery
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
Active, not recruiting
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Active, not recruitingPhase 2
Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer
NSCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Surgery and Right Ventricular Function, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Giustiniano EG Doctor, Anesthesiologist (0288247459, enrico.giustiniano@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic Measurement of RV dysfunction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.