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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035364
Receipt No. R000040300
Scientific Title A pilot study of robot assisted esophagectomy with nodal dissection for esophageal cancer using the da Vinci Xi surgical system
Date of disclosure of the study information 2018/12/26
Last modified on 2018/12/26

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Basic information
Public title A pilot study of robot assisted esophagectomy with nodal dissection for esophageal
cancer using the da Vinci Xi surgical
system
Acronym RATLE da Vinci
Scientific Title A pilot study of robot assisted esophagectomy with nodal dissection for esophageal
cancer using the da Vinci Xi surgical
system
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyuki Daiko
Organization National Cancer Center Hospital
Division name Division of Esophageal Surgery
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email hdaiko@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Kanamori
Organization National Cancer Center Hospital
Division name Division of Esophageal Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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