Clinical Research Directory

RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy

Sponsor: Shanghai Chest Hospital

Summary

This is a prospectively randomized controlled trial to compare RAMIE and MIE in the treatment for locally advanced ESCC after neoadjuvant therapy. According to previous studies, long-term survival after RAMIE seemed to be at least comparable to MIE or open esophagectomy. Therefore, the RAMIE-2 study was designed as a non-inferiority trial, which was based on the hypothesis that the 5-year overall survival of patients who received RAMIE is uncompromised to MIE. To achieve the primary endpoint, 260 cases will be recruited in our hospital. Based on the volume of esophagectomy (1000 cases/year) and the proportion of patients with neoadjuvant therapy (50%) in our institution, approximately 10 patients will be enrolled for each group per month for this trial. The study will be performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Written informed consent will be obtained from each participant. The flow chart of this trial is also presented.

Official title: Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial

Key Details

Conditions

Interventions

Locations (1)