UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027920 |
|---|---|
| Receipt number | R000030938 |
| Scientific Title | Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy |
| Date of disclosure of the study information | 2017/06/25 |
| Last modified on | 2017/06/25 11:28:21 |
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Basic information
Public title
Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy
Acronym
Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy
Scientific Title
Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy
Scientific Title:Acronym
Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy
Region
| Japan |
Condition
Condition
Pancreatic head cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the impact of the difference between PS and MS on clinical course of NACRT, surgery and economic impact.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the impact of difference between biliary stents on the period of NACRT and completion of NACRT.
Key secondary outcomes
duration of stent patency during NACRT, reintervention rate during NACRT, total number of reintervention during NACRT, hospital stay for reintervention during NACRT, R0 resection, surgical procedure, intraoperative characteristics, postoperative complications, mortality and hospital stays.the economic impact of maintaining preoperative biliary drainage with biliary stent.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with pancreatic head cancer who were performed biliary drainage with biliary plastic stent or metallic stent alone during neoadjuvant chemoradiothrapy, and underwent pancreatoduodenectomy or total pancreatectomy in the Department of Surgery at Nara Medical University between January 2008 and January 2017.
Key exclusion criteria
The patients who were treated with only neoadjuvant chemotherapy without radiation therapy.
The patients who were treated with adjuvant surgery after primary chemotherapy for locally advanced pancreatic cancer.
The patients who were treated by main biliary stent with endoscopic nasobiliary drainage (ENBD) or percutaneous drainage together at beginning of NACRT
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kota Nakamura |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijo-cho, Kashihara, Nara, JAPAN
TEL
0744-22-3051
knaka@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kota Nakamura |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijo-cho, Kashihara, Nara, JAPAN
TEL
0744-22-3051
Homepage URL
knaka@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical 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
| 2017 | Year | 06 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are neither duration of intervention nor observation in this study because this study is retrospective study in which the data of patients who underwent pancreatectomy are picked up from medical records.
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030938
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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