Feasibility study of Robot-Assisted Esophagectomy and Robot-Assisted Gastric Tube Reconstruction for the Patients with Locally Advanced Esophageal Carcinoma with the HinotoriTM Surgical Robot System

UMIN ID: UMIN000055313

Registered date:01/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Esophageal Carcinoma
• Date of first enrollment: 2024/10/10
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Robot-assisted esophagectomy and gastric tube reconstruction will be performed using the hinotori Surgical Robot System.

Outcome(s)

• Primary Outcome: Primary endpoint: Incidence rate of recurrent laryngeal nerve palsy of CTCAE v5.0 Grade 1 or higher / Clavien-Dindo classification Grade I or higher
• Secondary Outcome: Secondary endpoints: Operation time, amount of blood loss, incidence rate of intraoperative adverse events, rate of curative resection, incidence rate of postoperative pneumonia, incidence rate of anastomotic leakage, incidence rate of postoperative complications, length of postoperative hospital stay, and cost per surgery.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.The patient has active double/multiple cancers (synchronous or metachronous with a disease-free interval <5 years), excluding certain early-stage cancers or fully resected cases with a high survival rate. 2.The patient has a fever of 38 degrees Celsius or higher at registration. 3.The patient has a mental illness or psychiatric symptoms that hinder trial participation. 4.The patient is receiving ongoing systemic steroids or immunosuppressants. 5.The patient has uncontrolled diabetes despite medication. 6.The patient has uncontrolled hypertension. 7.The patient has unstable angina or a recent history of myocardial infarction (within 6 months). 8.The patient has uncontrolled valvular disease or cardiomyopathy. 9.The patient has interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by CT. 10.Other conditions deemed unsuitable by the investigator.

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Secondary Sponsor: SYSMEX CORPORATION
• Source(s) of Monetary Support: No funding provided