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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041035
Receipt No. 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 2020/07/08

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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
Email 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
Email viva.s.a.410@gmail.com

Sponsor
Institute Dokkyo Medical University Saitama Medical Center
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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