Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

Integrated University Hospital Trust of Verona

Status: Enrolling

Conditions: Gastric Cancer; Neoplasms; Gastric Neoplasm; Gastrointestinal Cancer; Gastric Diffuse Adenocarcinoma; Stomach Adenocarcinoma

Treatments: Device: Hugo™ RAS System; Device: Versius® Robotic Surgery System; Device: DaVinci® Surgical System

Study type: Interventional

Funder types: Other

Identifiers

NCT06362070

COMPAR-G

Details and patient eligibility

About

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:

• DaVinci;
• Hugo;
• Versius.

This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.

The questions it aims to answer are:

• Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
• Are there any differences between the three platforms related to the learning curve for surgeons?

Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:

1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.

Full description

Gastrectomy for gastric cancer could be performed through open, laparoscopic and robotic approaches. In the last ten years, robotic surgery, performed with Da Vinci® Robotic System (Intuitive Surgical Inc., Sunnyvale, CA, USA) has been introduced and increasingly used globally also in the field of gastric surgery. Indeed, the technological implementation obtained with the use of robotic surgery should guarantee an easier approach to the different phases of gastric surgery, and in particular to the more complex steps relating to the reconstructive phase of the operation.

Recently, after Intuitive patent expiration, two new CE-marked robotic platforms are available in Europe for minimally invasive procedures:

Versius® Robotic Surgery System, (Cambridge Medical Robotics (CMR) Ltd., Cambridge, UK); HugoTM RAS (Medtronic Dublin, Ireland; Minneapolis, MN, USA).

Both platforms are currently used for urological and gynecological procedures, but, no experiences are reported in Literature related to the field of oncological esophago-gastric surgery. In order to provide evidence regarding the new robotic platforms, the COMPAR-G study has been designed to directly compare the Da Vinci® (as standard), Versius® and HugoTM RAS robotic platforms during gastrectomy.

In this regard, this study was proposed, divided into two phases: a first phase for feasibility of surgical procedure with different platforms and the second one to evaluate the learning curve for surgeons.

This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 and < 80 years
• Informed consent provided
• Primary stomach tumor
• Total or subtotal gastrectomy
• Tumour stage: T1-4a, any N, M0
• ASA I-III
• No BMI limits
• Upfront surgery or after neoadjuvant chemotherapy

Exclusion criteria

• Extension to esophagectomy
• Tumor of the esophago-gastric junction (Siwert I-III)
• Emergency surgery
• Metastatic patients (stage IV)
• Patients undergoing preoperative radiotherapy
• Previous major supramesocolic surgery (excluding cholecystectomy)
• Other coexisting malignant neoplasms

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

DaVinci® Surgical System

Active Comparator group

Description:

Robot-assisted total or subtotal Gastrectomy is carried out through daVinci platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

Treatment:

Device: DaVinci® Surgical System

Hugo™ RAS System

Experimental group

Description:

Robot-assisted total or subtotal Gastrectomy is carried out through Hugo platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

Treatment:

Device: Hugo™ RAS System

Versius® Robotic Surgery System

Experimental group

Description:

Robot-assisted total or subtotal Gastrectomy is carried out through Versius platform. (10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

Treatment:

Device: Versius® Robotic Surgery System