Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery (the RIVER-2 Study)

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%)

Locations
Other Locations
Italy
Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Enrico Giustiniano EG Doctor, Anesthesiologist
enrico.giustiniano@humanitas.it
0288247459
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 100
Sponsors
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov