ClinicalTrials.gg
RecruitingNCT07362342RIVER-2Updated Jun 25, 2026

RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery

An observational study in Lung Surgery and Right Ventricular Function, sponsored by Istituto Clinico Humanitas. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Istituto Clinico Humanitas · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Lung Surgery
  • Right Ventricular Function
03

In context

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Prospective observational study in patients undergoing elective major thoracic surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged ≥18 years
  • Scheduled for elective lobectomy (or bilobectomy) via minimally invasive or open thoracic surgery
  • Ability to provide written at the time of hospital admission
  • Moderate to high cardiopulmonary risk, defined by at least one of the following criteria:

    • classification 3
    • Predicted postoperative \<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

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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Echocardiographic Measurement of RV dysfunction

    Measurement of TAPSE and/or S' wave using Tissue Doppler Imaging (TDI); TAPSE/PAPs ratio

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07362342
Responsible party
Michele Tedeschi (Medical Doctor, Istituto Clinico Humanitas) — Principal investigator
First posted
Jan 23, 2026
Start date
Jan 20, 2026
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Enrico Giustiniano EG Doctor, Anesthesiologist
Contact
enrico.giustiniano@humanitas.it
0288247459

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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