ATOM-ESO study

JRCT ID: jRCT1042240005

Registered date:04/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 10/06/2024
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Operate using the hinotori surgical robotics and collect surgical images and operation logs.

Outcome(s)

• Primary Outcome: Relation between goals and robot operation logs corresponding to specific motions/sections
• Secondary Outcome: Performance evaluation of hinotori regarding achievement targets corresponding to specific movements and sections

Key inclusion & exclusion criteria

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

Include criteria

(1) The age at the time of obtaining consent is 18 years or older.
(2) ECOG performance status (PS) is 0 or 1.
(3) Histologically proven esophageal cancer
(4) Radical esophagectomy and gastric tube reconstruction are planned for clinical stages 1-3.
(5) Major organ functions are preserved.
(6) After sufficient explanation of the trial details prior to registration, written consent has been obtained from the patient themselves.

Exclude criteria

(1) Previous radiation therapy to the mediastinum, including treatment for other cancer.
(2) Planned two-stage surgery.
(3) Patients who are judged to be unsuitable by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Tsubosa Yasuhiro
• Secondary Sponsor: Sysmex Corporation