UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046861