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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018651
Receipt No. 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

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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
Email 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
Email nshinno@gesurg.med.osaka-u.ac.jp

Sponsor
Institute LTG reconstruction method Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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