UMIN-CTR Clinical Trial

Basic information
Public title	Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer
Acronym	Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer
Scientific Title	Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer
Scientific Title:Acronym	Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital 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 retrospective study assessed the effect of weight loss during neoadjuvant therapy on failure to rescue after esophagectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	in-hospital mortality, failure to rescue
Key secondary outcomes	major complications, respiratory complications, anastomotic leakage, length of stay after surgery, total hospitalization costs

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent esophagectomy after neoadjuvant therapy between July 2010 and March 2019 were identified from a Japanese nationwide inpatient database.
Key exclusion criteria	The exclusion criteria were as follows:patients who underwent combined surgery for laryngeal or hypopharyngeal cancer; and patients who were outliers for height (<100 or >200 cm), weight (<20 or >200 kg), body mass index (BMI) (<12.5 or >60 kg/m2), or weight change during neoadjuvant therapy (>30% gain or >30% loss). We also excluded patients who underwent neoadjuvant therapy and esophagectomy during the same hospitalization.
Target sample size	15000

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Hirano
Organization	International University of Health and Welfare School of Medicine
Division name	Department of Hepatobiliary-Pancreatic and Gastrointestinal Surgery
Zip code	2868520
Address	852 Hatakeda, Narita, Chiba, Japan
TEL	0476355600
Email	yukihirano@iuhw.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Hirano
Organization	International University of Health and Welfare School of Medicine
Division name	Department of Hepatobiliary-Pancreatic and Gastrointestinal Surgery
Zip code	2868520
Address	852 Hatakeda, Narita, Chiba, Japan
TEL	0476355600
Homepage URL
Email	yukihirano@iuhw.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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	2022 Year 10 Month 13 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	15159
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	2022 Year 04 Month 01 Day
Date of IRB	2022 Year 05 Month 01 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2022 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This retrospective cohort study was conducted using the Diagnosis Procedure Combination database, a Japanese nationwide inpatient database More than 8 million hospital administrative claims data and discharge abstracts from more than 1200 hospitals are collected annually in this database. All university hospitals are required to participate in the database, while other hospitals participate on a voluntary basis.

Management information
Registered date	2022 Year 10 Month 13 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056046