UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018651 |
|---|---|
| Receipt number | R000021597 |
| Scientific Title | Randomized phase II trial of Circular stapler vs Linear stapler in esophagojejunostomy of laparoscopic total/proximal gastrectomy. |
| Date of disclosure of the study information | 2015/08/15 |
| Last modified on | 2015/09/07 15:50:59 |
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Basic information
Public title
Randomized phase II trial of Circular stapler vs Linear stapler in esophagojejunostomy of laparoscopic total/proximal gastrectomy.
Acronym
Randomized phase II trial of Circular stapler vs Linear stapler in esophagojejunostomy
Scientific Title
Randomized phase II trial of Circular stapler vs Linear stapler in esophagojejunostomy of laparoscopic total/proximal gastrectomy.
Scientific Title:Acronym
Randomized phase II trial of Circular stapler vs Linear stapler in esophagojejunostomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the anastomosis-related outcomes of Circular stapler and Linear stapler in laparoscopic esophagojejunostomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
anastomotic leakage rate of esophagojejunostomy until the postoperative first discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
esophagojejunostomy with Circular stapler
Interventions/Control_2
esophagojejunostomy with Linear stpler
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 diagnosed gastric cancer.
(2)total gastrectomy or proximal gastrectomy with esophagojejunostomy is planed.
(3)R0 or R1 with only CY1 surgery is possible.
(4)no invasion to esophagus or duodenum.
(5)ECOG PS0-2.
(6)BMI(Body Mass Index)<30
(7)normal hepatic, renal and marrow function
(8)written informed consent
Key exclusion criteria
(1) with severe complication or active dual malignancy
(2) judged as inappropriate by physician-in-charge
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3251
stakiguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Shinno |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3251
Homepage URL
nshinno@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
LTG reconstruction method Study Group
Institute
Department
Personal name
Funding Source
Organization
Osaka University Clinical Research Group for Gastroenterological Study
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 15 | 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
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021597
| Research Plan | |
|---|---|
| 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 |
