Clinical trial · Interventional
Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is the first randomized controlled study to compare the robot-assisted esophagectomy (RAE) to minimally invasive conventional thoracoscopic esophagectomy (CTE). The aim of this trial is to evaluate the safety, risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes and long-term oncological outcomes between the two surgical treatments.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robot assisted esophagectomy
- description
- Robot-assisted esophagectomy with gastric conduit formation.
- interventionNames
- Procedure: esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- Thoracoscopic esophagectomy
- description
- Conventional thoracoscopic esophagectomy with gastric conduit formation.
- interventionNames
- Procedure: esophagectomy
Primary outcomes (1)
- measure
- Overall Survival Rate
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous cell carcinoma of the intrathoracic esophagus. * Surgical resectable (T1b-3, N0-2, M0) * Age ≥ 18 and ≤ 75 years * European Clinical Oncology Group performance status 0, 1 or 2 * Written informed consent Exclusion Criteria: * Carcinoma of the cervical esophagus * Histologically proven adenocarcinoma or undifferentiated carcinoma. * Prior thoracic surgery at the right hemithorax or thorax trauma. * Infectious disease with systemic therapy indicated.
References
Publications (3)
- DERIVEDYang Y, Liu Z, Li C, Li B, Yu B, Yi J, Zhang X, Chen H, Li H, Tan L, Hua R, Guo X, Yang X, Ma W, Sun Y, Li Z; RAMIE study group. Robot-assisted versus conventional minimally invasive oesophagectomy for oesophageal squamous cell carcinoma (RAMIE): a multicentre, open-label, randomised, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 Jun;11(6):452-462. doi: 10.1016/S2468-1253(25)00402-9. Epub 2026 Mar 31. PMID 41932350
- DERIVEDYang Y, Li B, Yi J, Hua R, Chen H, Tan L, Li H, He Y, Guo X, Sun Y, Yu B, Li Z. Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Resectable Esophageal Squamous Cell Carcinoma: Early Results of a Multicenter Randomized Controlled Trial: the RAMIE Trial. Ann Surg. 2022 Apr 1;275(4):646-653. doi: 10.1097/SLA.0000000000005023. PMID 34171870
- DERIVEDYang Y, Zhang X, Li B, Li Z, Sun Y, Mao T, Hua R, Yang Y, Guo X, He Y, Li H, Chen H, Tan L. Robot-assisted esophagectomy (RAE) versus conventional minimally invasive esophagectomy (MIE) for resectable esophageal squamous cell carcinoma: protocol for a multicenter prospective randomized controlled trial (RAMIE trial, robot-assisted minimally invasive Esophagectomy). BMC Cancer. 2019 Jun 21;19(1):608. doi: 10.1186/s12885-019-5799-6. PMID 31226960