UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031131 |
|---|---|
| Receipt number | 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 22:22:55 |
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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
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
toasa0616@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
