UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025029 |
|---|---|
| Receipt number | R000028781 |
| Scientific Title | Cohort study of laparoscopic gastrectomy for advanced gastric cancer |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/12/01 09:19:27 |
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Basic information
Public title
Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Acronym
Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Scientific Title
Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Scientific Title:Acronym
Cohort study of laparoscopic gastrectomy for advanced gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of laparoscopic gastrectomy for advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of peritoneal cytology for carcinoma cells after surgery
Key secondary outcomes
Numbers of Group 2 lymph nodes, Proportion of laparoscopic gastrectomy completion, Incidence of adverse events, Incidence of anastomotic leakage or pancreatic fistula, Relapse-free survival, Overall survival
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 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)Aged 20 year over
2)PS (ECOG) 0 or 1
3)BMI < 30
4)Histologically proven gastric adenocarcinoma
5)Clinical T2, T3, T4a
6)Clinical N0-2, H0, P0, M0 without bulky N2
7)Resectability of RO
8)Written informed consent
Key exclusion criteria
1)With heart disease associated with symptoms
2)Wiht pulmorary disease requiring continuous oxygen therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Hayata |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
keiji@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Hayata |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
keiji@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University
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
Wakayama Medical University
Address
811-1 Kimiidera Wakayama
Tel
073-447-2300
keiji@wakayma-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
| 2016 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028781
