UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039413 |
|---|---|
| Receipt number | R000044938 |
| Scientific Title | Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy |
| Date of disclosure of the study information | 2020/02/07 |
| Last modified on | 2020/02/06 19:35:00 |
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Basic information
Public title
Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
Acronym
Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
Scientific Title
Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
Scientific Title:Acronym
Comparison of the incidences of anastomotic leakage when PDSII or LACLON are used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the incidences of anastomotic leakage
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
incidences of anastomotic leakage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
PDSII is used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
Interventions/Control_2
LACLON is used in esophagogastric conduit layer-to-layer handsewn anastomosis after esophagectomy
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
patients who received posterior mediastinal gastric conduit reconstruction with layer-to-layer handsewn anastomosis
Key exclusion criteria
patients who received other reconstruction organ and route
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sato |
Organization
Akita University Hospital
Division name
Esophageal surgery
Zip code
010-8543
Address
1-1-1, Hondo, Akita city, Japan
TEL
+81-18-884-6132
yusuke@doc.med.aktia-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sato |
Organization
Akita University Hospital
Division name
Esophageal surgery
Zip code
010-8543
Address
1-1-1, Hondo, Akita city, Japan
TEL
+81-18-884-6132
Homepage URL
yusuke@doc.med.aktia-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Akita University Graduate School of Medicine
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
Akita University Graduate School of Medicine
Address
1-1-1, Hondo, Akita city, Japan
Tel
+81-18-884-6132
yusuke@doc.med.aktia-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
2306
Org. issuing International ID_1
Akita University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 07 | 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
| 2019 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044938
