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RECRUITING
NCT07888140
PHASE3

Modular Robot-Assisted Versus Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This study evaluates the safety, efficacy, and health economic outcomes of modular robotic-assisted minimally invasive esophagectomy (RAMIE) compared with conventional thoracoscopic minimally invasive esophagectomy (MIE) in patients with resectable esophageal cancer. Participants are randomly assigned in a 1:1 ratio to undergo either modular robotic-assisted esophagectomy using the Carina™ Surgical Platform (experimental group) or conventional thoracoscopic esophagectomy (control group). The primary endpoint is the rate of Textbook Outcome (TO) within 30 days post-operation. Secondary endpoints include operative parameters, quality of life, overall survival, disease-free survival, and health economic metrics.

Official title: A Prospective, Multicenter, Randomized Controlled Trial Comparing Modular Robot-Assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Esophageal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-10-15

Completion Date

2031-10-30

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

PROCEDURE

Modular Robot-Assisted Esophagectomy

Robot-assisted minimally invasive esophagectomy performed using the Carina™ modular surgical platform for radical resection of resectable esophageal cancer. The procedure will be performed by trained surgeons using the Carina™ system and compatible surgical instruments.

PROCEDURE

Conventional Minimally Invasive Esophagectomy

Conventional minimally invasive esophagectomy performed using standard thoracoscopic and laparoscopic surgical techniques for radical resection of resectable esophageal cancer. Commercially available conventional endoscopic surgical equipment, including 3-dimensional thoracoscopic systems routinely used at participating centers, may be used.

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China