UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Title of the study (Brief title)	The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Region	Japan

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

Objectives
Narrative objectives1	To assess the impact of postoperative complications after esophagectomy on survivals
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease free survival rate, overall survival rate
Key secondary outcomes

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	Patients with esophageal cancer who underwent esophagectomy with thoracotomy and laparotomy, with R0 or R1 resection between January 1997 and December 2012 at Keio University Hospital, Tokyo, Japan.
Key exclusion criteria	Patients whose doctor judged to be ineligible for this study.
Target sample size	402

Research contact person
Name of lead principal investigator	Yuko Kitagawa
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	Hiroya Takeuchi
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	htakeuchi@a6.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 02 Month 07 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 06 Day
Anticipated trial start date	2015 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	To assess the impact of postoperative complications after esophagectomy on survivals

Management information
Registered date	2015 Year 02 Month 07 Day
Last modified on	2018 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019128