UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036621 |
|---|---|
| Receipt number | R000041721 |
| Scientific Title | Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/04/28 19:27:07 |
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Basic information
Public title
Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Acronym
Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Scientific Title
Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Scientific Title:Acronym
Single-arm feasibility study of laparoscopic gastrectomy for upper-third gastric cancer and esophago-gastric junction cancer
Region
| Japan |
Condition
Condition
Upper-third gastric cancer and esophago-gastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to validate non-inferiority in safety of laparoscopic gastrectomy compared to open gastrectomy for cT1N2-3, cT2N0-3, cT3N0 and cT4aN0 upper-third gastric cancer or esophago-gastric junction cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of anastomotic leakage
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
Laparoscopic proximal gastrectomy or laparoscopic total gastrectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically diagnosed as gastric or esophago-gastric adenocarcinoma.
2) Curatively resectable cT1N2-3M0, cT2N0-3M0, cT3N0M0 and cT4N0M0 (excluding bulky N2) cancer by proximal or total gastrectomy without splenectomy.
3) Older than 20 y.o.
4) PS 0~2
5) No previous treatment for gastric cancer.
6) BMI<35
7) Consented to be enrolled to the trial from participant him/herself.
Key exclusion criteria
1) Double cancer
2) cT4b
3) P1, Cy1 or cM1
4) Cases of received neoadjuvant treatment.
5) Pregnant or breast feeding.
6) Mental disorder
7) Continuous systemic administration of steroid.
8) Infectious disease with systemic treatment.
9) Uncontrollable diabetes mellitus.
10) Unstable coronary angina or history of MI within 6 months.
11) Respiratory disease with continuous administration of oxygen.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Soya |
| Middle name | |
| Last name | Nunobe |
Organization
Cancer Institute Hospital of JFCR
Division name
Gastroenterology Center
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
+81-3-3520-0111
souya.nunobe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | En |
| Middle name | |
| Last name | Amada |
Organization
Cancer Institute Hospital of JFCR
Division name
Gastroenterology Center
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
+81-3-3520-0111
Homepage URL
en.amada@jfcr.or.jp
Sponsor or person
Institute
JFCR
Institute
Department
Personal name
Funding Source
Organization
JFCR
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital of JFCR
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel
+81-3-3520-0111
en.amada@jfcr.or.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
| 2019 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | 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
| 2019 | Year | 04 | Month | 28 | Day |
Last modified on
| 2019 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041721
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
