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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039413
Receipt No. 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

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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
Email 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
Email yusuke@doc.med.aktia-u.ac.jp

Sponsor
Institute Akita University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044938

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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