Comparing robot-assisted and conventional minimally invasive surgery for esophageal cancer
Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Minimally Invasive Esophagectomy for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).
This study is testing whether robot-assisted surgery is better than traditional minimally invasive surgery for patients with esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Medical Center Mainz Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mainz) |
| Trial ID | NCT04306458 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of robot-assisted minimally invasive esophagectomy (RAMIE) compared to conventional minimally invasive esophagectomy (MIE) for patients with resectable esophageal adenocarcinoma. It is a multicenter randomized controlled trial that aims to assess lymph node dissection, efficacy, risks, quality of life, and cost-effectiveness of both surgical approaches. Patients aged 18 to 90 with histologically confirmed adenocarcinoma will be randomly assigned to receive either RAMIE or MIE. The study is conducted in accordance with ethical guidelines and aims to improve surgical outcomes for esophageal cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with histologically proven, surgically resectable esophageal adenocarcinoma.
Not a fit: Patients with esophageal squamous cell carcinoma or those who have had prior thoracic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing surgery for esophageal cancer.
How similar studies have performed: Previous studies have shown that both RAMIE and MIE are superior to open surgery, but this is the first randomized comparison between the two techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven adenocarcinoma of the intrathoracic esophagus and gastroesophageal junction (including Siewert I and II) * Surgically resectable (T1-4a, N0-3, M0) * Age ≥ 18 and ≤ 90 years * European Clinical Oncology Group (ECOG) performance status 0,1 or 2 * Written informed consent Exclusion Criteria: * Esophageal squamous cell carcinoma * Carcinoma of the cervical esophagus * Carcinoma of the gastro-esophageal junction (GEJ) with the main part of the tumor in the gastric cardia (Siewert type III) * Prior thoracic surgery at the right hemithorax or thoracic trauma
Where this trial is running
Mainz
- University Medical Center Mainz — Mainz, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Grimminger, MD,PhD — JGU Medizin Mainz, dept. AVTC
- Study coordinator: Pieter Christiaan van der Sluis, MD,PhD
- Email: p.c.vandersluis-2@umcutrecht.nl
- Phone: +31628880709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.