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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046119
Receipt No. R000052640
Scientific Title Safety and efficacy of circular stapler for esophagojejunostomy in laparoscopic total gastrectomy in gastric cancer
Date of disclosure of the study information 2021/11/19
Last modified on 2021/11/19

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Basic information
Public title Circular stapler for esophagojejunostomy in laparoscopic total gastrectomy in gastric cancer
Acronym Safety and efficacy of esophagojejunostomy in laparoscopic total gastrectomy
Scientific Title Safety and efficacy of circular stapler for esophagojejunostomy in laparoscopic total gastrectomy in gastric cancer
Scientific Title:Acronym LTG-CS study
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Develop a new method for esophagojejunostomy with circular stapler in laparoscopic total gastrectomy in gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of postoperative anastomotic-related complications
Key secondary outcomes survival

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 intracorporeal laparoscopic esophagojejunostomy
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Gastric cancer patients who under go laparoscopic total gastrectomy
Key exclusion criteria Gastric cancer patients who do not under go laparoscopic total gastrectomy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Dai
Middle name
Last name Manaka
Organization Kyoto Katsura Hospital
Division name Department of Surgery, Gastrointestinal Center
Zip code 615-825
Address 17 Yamada Hirao-cho, Nishikyo-ku, Kyoto, Japan
TEL 0753915811
Email d_manaka@katsura.com

Public contact
Name of contact person
1st name Dai
Middle name
Last name Manaka
Organization Kyoto Katsura Hospital
Division name Department of Surgery
Zip code 615-8256
Address 17 Yamada Hirao-cho, Nishikyo-ku, Kyoto, Japan
TEL 0753915811
Homepage URL
Email d_manaka@katsura.com

Sponsor
Institute Kyoto Katsura Hospital
Institute
Department

Funding Source
Organization Kyoto Katsura 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 Kyoto Katsura Hospital
Address 17 Yamada Hirao-cho, Nishikyo-ku, Kyoto, Japan
Tel 0753915811
Email d_manaka@katsura.com

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
2021 Year 11 Month 19 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 210
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 No longer recruiting
Date of protocol fixation
2010 Year 05 Month 01 Day
Date of IRB
2010 Year 06 Month 15 Day
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2023 Year 07 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
2021 Year 11 Month 19 Day
Last modified on
2021 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052640

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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