UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014924 |
|---|---|
| Receipt number | R000017353 |
| Scientific Title | A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2014/08/22 |
| Last modified on | 2018/07/06 21:24:18 |
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Basic information
Public title
A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer
Acronym
A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer
Scientific Title
A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer
Scientific Title:Acronym
A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer
Region
| Japan |
Condition
Condition
cStage I gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of laparoscopy assisted total or prioximal gastrectomy (LATG/PG) with nodal dissection for clinical stage IA or IB gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of anastomotic leakage
Key secondary outcomes
proportion of LAG completion, proportion of conversion to open surgery, proportion of anastomotic stenosis, Incidence of anastomotic stenosis, pancreatic fistula or peritoneal abscess, overall survival, recurrence-free survival, adverse events, short-term clinical outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopy assisted total and proximal 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma.
2) cStage IA or IB.
3) No indication of endoscopic mucosal resection (EMR) in a cN0 case.
4) Tumor located in the upper 1/3 of the stomach and indication for total or proximal gastrectomy.
5) No invasion to duodenum.
6) Aged 20 to 85 year.
7) Body mass index <30.
8) 13) Written informed consent.
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
2) Women during pregnancy or breast-feeding.
3) Severe mental disease.
4) Continuous systemic steroid therapy.
5) History of myocardial infarction or unstable angina pectoris within six months.
6) Uncontrollable hypertension.
7) Uncontrollable diabetes millutus.
8) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Misawa |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL
0527626111
misawakzn@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunari Misawa |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL
0527626111
Homepage URL
misawakzn@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
Address
Tel
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
愛知県がんセンター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 22 | Day |
Last modified on
| 2018 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017353
