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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018610
Receipt No. R000014169
Scientific Title Comparison of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer -Gambee anastomosis and Triangular anastomosis-
Date of disclosure of the study information 2015/08/10
Last modified on 2015/08/09

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Basic information
Public title Comparison of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer -Gambee anastomosis and Triangular anastomosis-
Acronym Comparison of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Scientific Title Comparison of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer -Gambee anastomosis and Triangular anastomosis-
Scientific Title:Acronym Comparison of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Region
Japan

Condition
Condition Thoracic esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine optimal anastomosis after esophagectomy, we compare Gambee anastomosis and Triangular anastomosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of anastomotic leakage
Incidence of anastomotic stricture
Time of anastomosis
Length of hospital stay
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 esophagogastric anastomosis by Gambee method
Interventions/Control_2 esophagogastric anastomosis by Triangular method
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Written informed consent : Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
2) Patients that esophagectomy for esophageal cancer is performed.
3) Reconstruction by gastric tube through retrosternal route
Key exclusion criteria 1) By operative findings, either of the anastomosis is judged inappropriate
2) Patients whom doctor judged to be ineligible for this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Shirakawa
Organization Okayama University Hospital
Division name Gastroenterological Surgery
Zip code
Address 2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan
TEL 086-235-7257
Email yasuwr@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoaki Maeda
Organization Okayama University Hospital
Division name Gastroenterological Surgery
Zip code
Address 2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan
TEL 086-235-7257
Homepage URL
Email p41n53io@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Gastroenterological Surgery
Institute
Department

Funding Source
Organization none
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
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 10 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 Preinitiation
Date of protocol fixation
2013 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 27 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 09 Day
Last modified on
2015 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014169

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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