Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Comparing robot-assisted and conventional minimally invasive surgery for esophageal cancer

Official title: Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Minimally Invasive Esophagectomy for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).

Run by University Medical Center Mainz · NCT04306458 · Data updated 2026-11-12

This study is testing whether robot-assisted surgery is better than traditional minimally invasive surgery for patients with esophageal cancer.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment218 (estimated)
SponsorUniversity Medical Center Mainz
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Mainz)
StatusRecruiting
StartedJanuary 18, 2021
Main results expectedMay 19, 2023
Study endsJanuary 19, 2028
Registry record updatedMay 17, 2022
Trial IDNCT04306458 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 90 with histologically proven, surgically resectable esophageal adenocarcinoma.

Probably not a fit

Patients with esophageal squamous cell carcinoma or those who have had prior thoracic surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University Medical Center Mainz
    Mainz, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.