UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018610 |
|---|---|
| Receipt number | 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 | 2025/01/03 13:28:36 |
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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
Key secondary outcomes
Incidence of anastomotic stricture(number of balloon dilatations performed within one year after surgery)
Anastomosis time
Hospital expenses(difference in the number of calculation points before and after the application of the Diagnosis Procedure Combination system)
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
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Shirakawa |
Organization
Okayama University Hospital
Division name
Gastroenterological Surgery
Zip code
7008558
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan
TEL
086-235-7257
yasuwr@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoaki |
| Middle name | |
| Last name | Maeda |
Organization
Okayama University Hospital
Division name
Gastroenterological Surgery
Zip code
7008558
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan
TEL
086-235-7257
Homepage URL
p41n53io@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikatacho Kita-ku, Okayama-shi, Okayama-ken 700-0914 Japan
Tel
086-235-6503
mae6605@adm.okayama-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 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014169
