UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survival benefit of conversion surgery for patients with initially unresectable pancreatic cancer who responded to non-surgical treatment favorably.
Title of the study (Brief title)	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	Satoshi Hirano
Organization	Hokkaido University Faculty of Medicine
Division name	Department of Gastroenterological Surgery II
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	Toshimichi Asano
Organization	Hokkaido University Faculty of Medicine
Division name	Department of Gastroenterological Surgery II
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29797499
Results
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