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A randomized controlled phase 2 trial comparing the safety and usefulness of robot-assisted esophagectomy and thoracoscopic

A randomized controlled phase 2 trial comparing the safety and usefulness of robot-assisted esophagectomy and thoracoscopic - ROBOCOP

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1040220153
Enrollment
90
Registered
2023-02-28
Start date
2023-02-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer and gastroesophageal junction cancer Roboto-assisted esophagectomy

Interventions

In this study, cStage (1 vs. 2 or more) and dissection area (2 regions vs. 3 regions) were used as allocation factors, and the UMIN INDICE cloud system was used to allocate patients to the robot-assis
Robot-assisted esophagectomy, thoracoscopic esophagectomy

Sponsors

Takeuchi Hiroya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Intended for patients who meet all of the following criteria 1.Patients over 18 years old 2. Patients diagnosed with esophageal or gastroesophageal junction cancer 3. Patients scheduled for subtotal thoracic esophagectomy with bilateral recurrent laryngeal perineural lymph node (#106recR and #106recL) dissection 4. Those who have obtained consent to participate in this research by signing a consent form by themselves or their proxy

Exclusion criteria

Exclusion criteria: Patients who meet any of the following conditions will not be included in this study. 1. Subjects with recurrent laryngeal nerve palsy before surgery 2. Patients with heart disease (NYHA III-IV, severe arrhythmia) 3. Subjects with severe liver disorder (fulminant hepatitis, hepatic encephalopathy, Child-Pugh classification Grade C) 4. Subjects with severe renal impairment (chronic kidney disease stage 4 or 5 according to CKD guidelines) 5. Women who are pregnant or may become pregnant 6. breastfeeding woman 7. Subjects with dementia 8. Those judged inappropriate by the investigator

Design outcomes

Primary

MeasureTime frame
Recurrent laryngeal nerve palsy (Clavien-Dindo (CD) classification 2 or higher)

Secondary

MeasureTime frame
Postoperative complications (pneumonia, anastomotic leakage, recurrent laryngeal nerve paralysis (CD-Grade 1 or higher), pleural effusion, chylothorax, etc.), bleeding amount, operation time, number of lymph nodes dissected, delirium incidence, overall survival, recurrence-free survival rate

Contacts

Public ContactEisuke Booka

1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan

booka@hama-med.ac.jp+81-53-435-2279

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026