UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041035 |
|---|---|
| Receipt number | R000046861 |
| Scientific Title | A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy |
| Date of disclosure of the study information | 2020/07/08 |
| Last modified on | 2022/07/20 15:59:23 |
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Basic information
Public title
A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy
Acronym
A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy
Scientific Title
A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy
Scientific Title:Acronym
A prospective study to examine the usefulness and safety of 6mm diameter covered metallic stent insertion for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively examine the usefulness and safety of the covered metallic stent in patients with a 6 mm diameter covered metallic stent for biliary drainage in patients with pancreatic cancer undergoing preoperative chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of recurrent biliary obstruction (RBO) that develops before surgery
Key secondary outcomes
(1)Time to recurrent biliary obstruction (TRBO)
(2) Incidence of cholecystitis
(3) Adverse events other than RBO
(4) Impact on surgery
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
1) Patients aged 20 years or older at the time of obtaining consent
2)Patients diagnosed with pancreatic cancer by histological diagnosis or imaging tests (CT or MRI)
3) Patients with middle and lower bile duct stenosis
4) Patients who have been judged by a doctor to be able to place a self-expanding metal stent (SEMS)
5) Patients scheduled to undergo preoperative chemotherapy (NAC)
6) Patients scheduled for surgery
7) Patients who can obtain their consent for participation in this study
Key exclusion criteria
1) Patients with Performance status 3 or 4
2) Women who are pregnant or may be pregnant
3) Patients with severe complications that affect resection or chemotherapy such as heart disease, liver disease, renal disorder
4) Patients with a distance from the hilum of the stenosis to the upper end of the stenosis of 2 cm
5) Patients with Gastic outlet obstruction due to anal stenosis
6) Cases where endoscopic approach is difficult
7) Reconstruction other than Billroth 1 method after gastrectomy
8) Cases with distant metastasis
9) Patients who are judged to be inappropriate as a subject by the doctor's judgment
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasumi |
| Middle name | |
| Last name | Katayama |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Gastroenterology
Zip code
343-8555
Address
2-1-50,Minami Koshigaya,Koshigaya-shi,Saitama
TEL
048-965-1111
yasumi@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Ikuhiro |
| Middle name | |
| Last name | Kobori |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Gastroenterology
Zip code
343-8555
Address
2-1-50,Minami Koshigaya,Koshigaya-shi,Saitama
TEL
048-965-1111
Homepage URL
viva.s.a.410@gmail.com
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Saitama Medical Center
Address
2-1-50,Minami Koshigaya,Koshigaya-shi,Saitama
Tel
048-965-1111
m-iyama@dokkyomed.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
| 2020 | Year | 07 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2020 | Year | 07 | Month | 08 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046861
