UMIN-CTR Clinical Trial

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

esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

the achievement rate of robotic esophagectomy

Key secondary outcomes

the incidence of postoperative laryngeal nerve palsy and other complications

Study type

Interventional

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

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

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

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

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

Institute

National Cancer Center

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

12

Month

26

Day

Last modified on

2018

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040300