UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018617
Receipt No. R000020838
Scientific Title Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Date of disclosure of the study information 2015/09/01
Last modified on 2016/10/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Acronym Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Scientific Title Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and esophageal cancer
Scientific Title:Acronym Investigation of safety and feasibility of esophagectomy for patients with multiple primary cancer and 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 The purpose of this study is to evaluate the difference of post-operative complication and survival between single primary cancer and multiple primary cancer. Also, clarify the risk factor of operation in multiple primary cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes post-operative complication, overall survival rate, esophageal cancer specific survival rate
Key secondary outcomes operation time, reconstruction method, blood loss, operation related death, treatment of other primary cancer, histology type, TNM classification

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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who were diagnosed as esophageal cancer
2. age; over 20 years old and under 85 years old
3. Patients without recurrence of antecedent cancers.
Key exclusion criteria Whenever the patients or the bereaved families rejected to use the data for the clinical study
Target sample size 294

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Kakeji
Organization Kobe University Graduate School of Medicine
Division name Division of Gastrointesitnal
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe city
TEL 078-382-5925
Email kakeji@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsu Nakamura
Organization Kobe University Graduate School of Medicine
Division name Division of Gastrointesitnal Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe city
TEL 078-382-5925
Homepage URL
Email tetsun@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine, Division of Gastrointesitnal Surgery
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine, Division of Gastrointesitnal Surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2015 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective, case control study

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.