Clinical trial · Interventional
Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial
Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial
NCT03713749CI-TRIAL-00052504unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.
Conditions
Conditions (1)
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 Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot esophagectomy (RE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robot Esophagectomy (RE)
- description
- Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy.
- interventionNames
- Device: Robot esophagectomy (RE)
- type
- NO_INTERVENTION
- label
- Video-assisted thoracoscopic esophagectomy (VATE)
- description
- Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy.
Primary outcomes (1)
- measure
- Rate of unsuccessful LND along the left RLN
- timeFrame
- Till 6 months postoperatively
- description
- Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary \[i.e., recovering within 6 months\] versus permanent \[i.e. not recovering within 6 months\]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria 1. Age between 18\~80 2. Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND. 3. Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group. 4. Surgical resectable(cT1\~4a, N0\~3, M0) 5. Written informed consent Exclusion criteria are 1. Previous major thoracic surgery rendering minimal invasive approach unfeasible 2. prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up 3. inability to provide oral or written informed consent. 4. pre-existed vocal cord dysfunction will also be excluded.
References
Publications (29)
- BACKGROUNDUdagawa H, Ueno M, Shinohara H, Haruta S, Kaida S, Nakagawa M, Tsurumaru M. The importance of grouping of lymph node stations and rationale of three-field lymphoadenectomy for thoracic esophageal cancer. J Surg Oncol. 2012 Nov;106(6):742-7. doi: 10.1002/jso.23122. Epub 2012 Apr 13. PMID 22504922
- BACKGROUNDMizutani M, Murakami G, Nawata S, Hitrai I, Kimura W. Anatomy of right recurrent nerve node: why does early metastasis of esophageal cancer occur in it? Surg Radiol Anat. 2006 Aug;28(4):333-8. doi: 10.1007/s00276-006-0115-y. Epub 2006 May 23. PMID 16718401
- BACKGROUNDSato Y, Kosugi S, Aizawa N, Ishikawa T, Kano Y, Ichikawa H, Hanyu T, Hirashima K, Bamba T, Wakai T. Risk Factors and Clinical Outcomes of Recurrent Laryngeal Nerve Paralysis After Esophagectomy for Thoracic Esophageal Carcinoma. World J Surg. 2016 Jan;40(1):129-36. doi: 10.1007/s00268-015-3261-8. PMID 26464155
- BACKGROUNDFujita H, Sueyoshi S, Tanaka T, Fujii T, Toh U, Mine T, Sasahara H, Sudo T, Matono S, Yamana H, Shirouzu K. Optimal lymphadenectomy for squamous cell carcinoma in the thoracic esophagus: comparing the short- and long-term outcome among the four types of lymphadenectomy. World J Surg. 2003 May;27(5):571-9. doi: 10.1007/s00268-003-6913-z. Epub 2003 Apr 28. PMID 12715226
- BACKGROUNDGockel I, Kneist W, Keilmann A, Junginger T. Recurrent laryngeal nerve paralysis (RLNP) following esophagectomy for carcinoma. Eur J Surg Oncol. 2005 Apr;31(3):277-81. doi: 10.1016/j.ejso.2004.10.007. PMID 15780563
- BACKGROUNDBerry MF, Atkins BZ, Tong BC, Harpole DH, D'Amico TA, Onaitis MW. A comprehensive evaluation for aspiration after esophagectomy reduces the incidence of postoperative pneumonia. J Thorac Cardiovasc Surg. 2010 Dec;140(6):1266-71. doi: 10.1016/j.jtcvs.2010.08.038. Epub 2010 Sep 29. PMID 20884018
- Hulscher JB, van Sandick JW, Devriese PP, van Lanschot JJ, Obertop H. Vocal cord paralysis after subtotal oesophagectomy. Br J Surg. 1999 Dec;86(12):1583-7. doi: 10.1046/j.1365-2168.1999.01333.x.