UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023060 |
|---|---|
| Receipt number | R000026262 |
| Scientific Title | Feasibility and safety of robotic esophagectomy for esophageal cancer using da Vinci Surgical System |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/07/30 09:53:46 |
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Basic information
Public title
Feasibility and safety of robotic esophagectomy for esophageal cancer using da Vinci Surgical System
Acronym
Robotic esophagectomy for esophageal cancer
Scientific Title
Feasibility and safety of robotic esophagectomy for esophageal cancer using da Vinci Surgical System
Scientific Title:Acronym
Robotic esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine feasibiliy and safety of robotic esophagectomy for esophageal cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
morbidity (Clavien-Dindo Grade over IIIa)
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Robotic esophagectomy
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)Pathorogically diagnosed primary esophageal squamous cell carcinoma or adenocarcinoma
2)clinical Stage 0-III
3)Not meeting the indications for endoscopic resection
4) patient's own written informed concent is obtained.
Key exclusion criteria
1)Patients with a mental disorder who have difficulties in participating in the present study
2)Preoperative therapy excluding non-curative endoscopic resection and standarad neoadjuvant chemotherapy for cStageII/III disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo, 160-8582 Japan
TEL
03-3353-1211
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo, 160-8582 Japan
TEL
03-3353-1211
Homepage URL
hkawakubo@z3.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjyuku, Tokyo, 160-8582 Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026262
