UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029066
Receipt number R000032850
Scientific Title Clinical evaluation of the safety of robotic esophagectomy using da Vinci surgical system (DVSS) for resectable esophageal cancer
Date of disclosure of the study information 2017/10/01
Last modified on 2019/03/13 15:51:56

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Basic information

Public title

Clinical evaluation of the safety of robotic esophagectomy using da Vinci surgical system (DVSS) for resectable esophageal cancer

Acronym

Robotic esophagectomy for esophageal cancer

Scientific Title

Clinical evaluation of the safety of robotic esophagectomy using da Vinci surgical system (DVSS) for resectable esophageal cancer

Scientific Title:Acronym

Robotic esophagectomy for esophageal cancer

Region

Japan


Condition

Condition

Esophageal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify safety of robotic esophagectomy using DVSS for esophageal cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Postoperative complications greater than Grade III according to Clavien-Dindo classification during 30 days after surgery

Key secondary outcomes

Postoperative complications greater than Grade II according to Clavien-Dindo classification during 30 days after surgery
Completion rate of robot assised surgery
The incidence of Intraoperative adverse effects
Surgery-related mortality


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

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 surgery

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically diagnosed primary esophageal squamous cell carcinoma or adenocarcinoma
2) cStage I, II or III disease curably treated with radical esophagectomy
3) Not indicated for endoscopic resection
4) Informed consent is obtained

Key exclusion criteria

1) Patients with psychiatric or mental disorders
2) Preoperative therapy excluding non-curative endoscopic resection and standarad neoadjuvant chemotherapy for cStageII/III disease
3) Possibly pregnant, or breast feeding woman
4) Paticents with acute myocardial infaction in 6 months or with unstable ungina

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroya
Middle name
Last name Takeuchi

Organization

Hamamatsu University School of Medicine

Division name

Department of Surgery

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN

TEL

053-435-2279

Email

takeuchi@hama-med.ac.jp


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Hiramatsu

Organization

Hamamatsu University School of Medicine

Division name

Department of Surgery

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN

TEL

053-435-2279

Homepage URL


Email

hiramatu@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

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

Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN

Tel

053-435-2680

Email

rinri@hama-med.ac.jp


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

2017 Year 10 Month 01 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

Open public recruiting

Date of protocol fixation

2017 Year 09 Month 08 Day

Date of IRB

2017 Year 10 Month 12 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 08 Day

Last modified on

2019 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032850


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name