UMIN-CTR Clinical Trial

Basic information
Public title	Impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer
Acronym	Impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer
Scientific Title	Risk factors for operative morbidity and mortality after esophagectomy for esophageal cancer
Scientific Title:Acronym	Risk factors for operative morbidity and mortality after esophagectomy for esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to evaluate the impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	the occurrence of anastomotic leakage
Key secondary outcomes	surgical site infection, respiratory complications, cardiovascular complications, operative morbidity, operative mortality, and length of hospital stay after surgery

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A two-center database (2011-2019) was retrospectively reviewed to identify patients with esophageal cancer who underwent esophagectomy.
Key exclusion criteria	Patients who underwent two-stage reconstruction or who were missing HbA1c values were excluded from the study.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Daiko
Organization	National Cancer Center Hospital
Division name	Division of Esophageal Surgery
Zip code	1040045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	+81-3-3542-2511
Email	hdaiko@ncc.go.jp

Public contact
Name of contact person	1st name Junya Middle name Last name Oguma
Organization	National Cancer Center Hospital
Division name	Division of Esophageal Surgery
Zip code	1040045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	+81-3-3542-2511
Homepage URL	https://www.ncc.go.jp/jp/about/research_promotion/study/list/2020-303.pdf
Email	joguma@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	International University of Health and Welfare School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Ethics Committee at National Cancer Center
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel	+81-3-3542-2511
Email	irst@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2020-303
Org. issuing International ID_1	the Ethics Committee at National Cancer Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、国際医療福祉大学医学部（千葉県）

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 11 Day

Related information
URL releasing protocol	https://www.ncc.go.jp/jp/about/research_promotion/study/list/2020-303.pdf
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	2154
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	Completed
Date of protocol fixation	2020 Year 11 Month 08 Day
Date of IRB	2020 Year 12 Month 08 Day
Anticipated trial start date	2021 Year 01 Month 08 Day
Last follow-up date	2022 Year 04 Month 11 Day
Date of closure to data entry	2022 Year 07 Month 11 Day
Date trial data considered complete	2022 Year 07 Month 11 Day
Date analysis concluded	2022 Year 07 Month 11 Day

Other
Other related information	This study aimed to evaluate the impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer.

Management information
Registered date	2022 Year 04 Month 11 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054117