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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041737
Receipt No. R000045492
Scientific Title A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Date of disclosure of the study information 2020/09/09
Last modified on 2020/09/10

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Basic information
Public title A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Acronym PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT
Scientific Title A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Scientific Title:Acronym PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Basic objectives2 Others
Basic objectives -Others Non-inferiority
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biliary event rate until surgery after biliary stenting with a metal stent
Key secondary outcomes (1) curative resection rate
(2)Time to Recurrent biliary obstruction
(3)Chemotherapy accomplishment/delay/discontinuation
(4)Other stent-related adverse events
(5)Frequency and severity of adverse events after curative surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Uncovered stent
Interventions/Control_2 Partially covered stent
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 Pancreatic cancer patients with jaundice scheduled for neoadjuvant chemo-/chemoradiotherapy:
(1) pathological diagnosis of pancreatic ductal adenocarcinoma/adenosquamous carcinoma; (2) clinical diagnosis of resectable/borderline resectable pancreatic cancer according to the 7th edition of the General Rules for the Study of Pancreatic Cancer by the Japan Pancreas Society, which is almost equal to National Comprehensive Cancer Network (NCCN) Guideline Version 1.2020; (3) scheduled for neoadjuvant chemotherapy/chemoradiotherapy; (4) with distal biliary obstruction which requires endoscopic biliary drainage (or with history of endoscopic/percutaneous transhepatic biliary drainage using a plastic stent/tube; (5) being 20 or more years of age and (6) providing informed consent
Key exclusion criteria (1) history of biliary drainage with a metal stent; (2) history of chemotherapy/chemoradiotherapy for pancreatic cancer; (3) biliary obstruction that progresses to the hepatic hilum; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 4; (5) history of gastrointestinal tract reconstruction except for Billroth I reconstruction; (6) the major duodenal papilla unreachable by a duodenal endoscope; (7) pregnancy or suspected pregnancy; (8) unsuitable for inclusion at the discretion of the physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code 060-8648
Address West 5, North 14, Kita-ku, Sapporo
TEL 011-716-1161
Email mkuwatan@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code 060-8648
Address West 5, North 14, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email mkuwatan@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
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 Hokkaido University Certified Review Board
Address West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel 011-706-7934
Email recjimu@huhp.hokudai.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 09 Month 09 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 03 Month 17 Day
Date of IRB
2020 Year 03 Month 17 Day
Anticipated trial start date
2020 Year 09 Month 16 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 09 Day
Last modified on
2020 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045492

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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