UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016496 |
|---|---|
| Receipt number | R000019124 |
| Scientific Title | A Phase II study of robot assisted laparoscopic distal gastrectomy for clinical stage IA gastric cancer |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2019/08/14 15:49:43 |
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Basic information
Public title
A Phase II study of robot assisted laparoscopic distal gastrectomy for
clinical stage IA gastric cancer
Acronym
A Phase II study of robot assisted gastrectomy
Scientific Title
A Phase II study of robot assisted laparoscopic distal gastrectomy for
clinical stage IA gastric cancer
Scientific Title:Acronym
A Phase II study of robot assisted gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer with cStage IA
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robot assisted laparoscopic distal gastrectomy for cStage IA gastric cancer not applicable for endoscopic submucosal dissection in the introductory period
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence rate of intra-abdominal complications requiring treatment (postoperative bleeding, anastomotic leakage, intraabdominal abscess, pancreatic fistula)
Key secondary outcomes
Overall survival, Relapse-free survival, Completion rate of robot assisted laparoscopic surgery, Proportion of open conversion, Short-term postoperative course
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 | Maneuver |
Interventions/Control_1
Robot assisted laparoscopic distal 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma
2) Diagnosed as cStageIA(T1N0) by endoscopy and contrast enhanced CT
3) Not applicable for endoscopic submucosal dissection
4) Regarded as curatively resected by distal gastrectomy with tumor location being M, L, ML, or LM
5) Performance status of 0 or 1
6) Body Mass Index of less than 30
7) No prior surgery in the upper abdomen
8) No prior chemotherapy or radiation therapy for cancers including gastric cancer
9) Informed consent obtained from the patient
Key exclusion criteria
1) Active mutiple primary cancers (carcinoma in situ or mucosal cancer were not included in active cancers)
2) Being pregnant or brestfeeding
3) Continuous steroid use (oral or intravenous)
4) With myocardial infarction in 6 months or with unstable angina
5) With uncontrollable hypertension
6) With uncontrollable diabetes mellitus
7) With respiratory disorder requiring continuous oxgen therapy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University
Division name
Department of surgery
Zip code
2520374
Address
1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
gekaw@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Hosoda |
Organization
Kitasato University
Division name
Department of surgery
Zip code
2520374
Address
1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
k.hosoda@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
Research Ethics Committee of the Kitasato University School of Medicine
Address
1-15-1 Kitasato, Sagamihara, Japan
Tel
0427788111
rinrib@med.kitasato-u.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
| 2015 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.journalofsurgicalresearch.com/article/S0022-4804(19)30054-X/fulltext
Number of participants that the trial has enrolled
25
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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019124
