UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031131
Receipt No. R000035560
Scientific Title Survival benefit of conversion surgery for patients with initially unresectable pancreatic cancer who responded to non-surgical treatment favorably.
Date of disclosure of the study information 2018/02/07
Last modified on 2018/07/10

* 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 Survival benefit of conversion surgery for patients with initially unresectable pancreatic cancer who responded to non-surgical treatment favorably.
Acronym Conversion surgery for patients with UR-PC
Scientific Title Survival benefit of conversion surgery for patients with initially unresectable pancreatic cancer who responded to non-surgical treatment favorably.
Scientific Title:Acronym Conversion surgery for patients with UR-PC
Region
Japan

Condition
Condition unresectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We analyzed outcomes of conversion surgery (CS) for patients with unresectable pancreatic cancer (UR-PC), and evaluated the survival benefit of CS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
80 years-old >=
Gender Male and Female
Key inclusion criteria I) Patients diagnosed as unresectable pancreatic cancer
II) Patients with favorable responses to non-surgical treatment
III) Patients who underwent conversion surgery
IV) Patients who refuse to participate in this research
Key exclusion criteria Patients judged inappropriate as research subjects by research managers
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hirano
Organization Hokkaido University Faculty of Medicine
Division name Department of Gastroenterological Surgery II
Zip code
Address N-15, W-7, Kita-ku, Sapporo, Hokkaido
TEL 011-706-7714
Email satto@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimichi Asano
Organization Hokkaido University Faculty of Medicine
Division name Department of Gastroenterological Surgery II
Zip code
Address N-15, W-7, Kita-ku, Sapporo, Hokkaido
TEL 011-706-7714
Homepage URL
Email toasa0616@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
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
2018 Year 02 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29797499
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 Completed
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 07 Day
Last follow-up date
2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 04 Month 01 Day
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information Background information: age, sex, medical history,
Non-surgical treatment information: treatment, drug used, treatment period, treatment effect judgment
Tumor marker: CEA, CA19-9
Surgical information: operative method, operation time, amount of bleeding
Postoperative information: postoperative complication, postoperative hospital stay
Information on postoperative information: presence or absence of postoperative adjuvant chemotherapy (drug, duration) Presence or absence of recurrence (presence or absence of treatment, content, duration), presence / absence of death, cause of death

Management information
Registered date
2018 Year 02 Month 04 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.