UMIN-CTR Clinical Trial

Basic information
Public title	A Korea-Japan multicenter joint project on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Acronym	A Korea-Japan multicenter joint project on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Scientific Title	A Korea-Japan multicenter joint project on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Scientific Title:Acronym	A Korea-Japan multicenter joint project on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Region	Japan Asia(except Japan)

Condition
Condition	Ampulla of Vater Cancer
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate postoperative adjuvant treatment for ampulla of vater carcinoma To compare the overall survival rates of ampulla of vater carcinoma according to postoperative adjuvant therapy. To compare the disease free survival rates of ampulla of vater carcinoma according to postoperative adjuvant therapy. The final goal of this study is to evaluate postoperative adjuvant treatment for ampulla of vater cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3 year & 5 year overall survival 3 year & 5 year disease free survival
Key secondary outcomes	Recurrence patterns according to postoperative adjuvant treatment.

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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent operation for ampulla of vater carcinoma and diagnosis confirmed by histopathology between 2002. 1 and 2015. 12 Patients who underwent completed resection of tumor (included only R0 resection)
Key exclusion criteria	Patients without available data in the case report form (CRF) Patients with combined cancer 30-day mortality case associated with operative complication Patients with neoadjuvant treatment Patients with R1/R2 resection of tumor
Target sample size	1090

Research contact person
Name of lead principal investigator	1st name Itaru Middle name Last name Endo
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Zip code	2360004
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	0457872650
Email	endoit@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Yabushita
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Zip code	2360004
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	0457872650
Homepage URL
Email	yabu23@yokohama-cu.ac.jp

Sponsor
Institute	Japanese Society of Hepato-Biliary-Pancreatic Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Korean Association of Hepato-Biliary-Pancreatic Surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Ethics Committee
Address	3-9 Fukuura Kanazawaku Yokohama
Tel	0457872800
Email	rinri@yokohama-cu.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	2019 Year 09 Month 05 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	Main results already published
Date of protocol fixation	2019 Year 04 Month 17 Day
Date of IRB	2019 Year 02 Month 22 Day
Anticipated trial start date	2019 Year 04 Month 17 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 10 Month 19 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective cohort stud

Management information
Registered date	2019 Year 09 Month 03 Day
Last modified on	2021 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043218