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

JRCT ID: jRCT1040220153

Registered date:28/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal cancer and gastroesophageal junction cancer
• Date of first enrollment: 28/02/2023
• Target sample size: 90
• Study type: Interventional
• Intervention(s): 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-assisted group and the thoracoscopic group.

Outcome(s)

• Primary Outcome: Recurrent laryngeal nerve palsy (Clavien-Dindo (CD) classification 2 or higher)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takeuchi Hiroya
• Source(s) of Monetary Support: JATS