UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of robot assisted esophagectomy with nodal dissection for esophageal cancer using the da Vinci Xi surgical system
Title of the study (Brief title)	RATLE da Vinci
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the safety of robotic esophagectomy with lymphadenectomy for resectable esophageal cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the achievement rate of robotic esophagectomy
Key secondary outcomes	the incidence of postoperative laryngeal nerve palsy and other complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	robotic esophagectomy with lymphadenectomy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Staging of tumor is performed according to the UICC/AJCC 7th edition of the TNM Classification of Malignant Tumours. To be eligible for this study, patients must fulfill all of the following criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. 2) Primary tumor located in thoracic esophagus. Tumor which is centrally located more than 2 cm below of the esophago-gastric junction is ineligible 3) Either single lesion or multiple lesions. Second tumors in cervical esophagus which is indicated for EMR/ESD are also eligible. 4) Clinical stages I, II or III (excluding T4b) based on the 7th UICC-TNM classification. 5) Aged 20 to 80 years. 6) No prior lateral thoracotomy (or thoracoscopic surgery) on right side or no prior lobectomy or more extended surgery on left side was performed. 7) No prior treatment against esophageal cancer except for i)-iii) i) Non-curative resection for primary tumor by EMR/ESD. ii) Clinical stage IB, II or III esophageal cancer patients who received 2 courses or less of cisplatin plus fluorouracil. iii) Curative resection had been achieved by EMR/ESD against metachronous multiple cancer. 8) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of adjuvant hormonal therapy after more than 1 year from the last administration is eligible. 9) No prior gastrectomy. 10) Sufficient organ functions. i. WBC >= 3,000/mm3 ii. Platelet >= 100,000/mm3 iii. Hemoglobin >=10mgldL iv. AST =< 100 IU/L , ALT =< 100 IU/L v. T.Bil =< 2.0 mg/dL vi. Creatinine =< 1.5 mg/dL 11) Written informed consent.
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Pregnancy or breast-feeding. 3) Severe psychiatric disease. 4) Continuous systemic steroid or immune-suppressive drug therapy. 5) Unstable angina pectoris, or history of myocardial infarction within six months 6) Poorly controlled hypertension. 7) Poorly controlled diabetes mellitus in spite of continuous use of insulin. 8) BMI of 30 or more. 9) Other reasons of not to perform robotic esophagectomy
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroyuki Daiko
Organization	National Cancer Center Hospital
Division name	Division of Esophageal Surgery
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	hdaiko@ncc.go.jp

Public contact
Name of contact person	Jun Kanamori
Organization	National Cancer Center Hospital
Division name	Division of Esophageal Surgery
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	jkanamor@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 28 Day
Anticipated trial start date	2018 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 26 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040300