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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041704
Receipt No. R000047585
Scientific Title Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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Basic information
Public title Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Acronym Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Scientific Title Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Scientific Title:Acronym Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate the clinical safety and efficacy of 6mm diameter Fully covered self-expandable metallic stent (FCSEMS) in endoscopic biliary drainage for obstructive jaundice during preoperative chemotherapy for pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Stent-related complications (pancreatitis, non-occlusion cholangitis, cholecystitis, bleeding, perforation)
Key secondary outcomes Non biliary obstruction rates of per resectable and borderline pancreatic cancer.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 New therapy: Endoscopic Biliary Drainage by 6mm diameter fully covered self-expandable metallic stent.
Observation period: 30days after surgery from the date of stent deployment or the date of the decision not to resect the pancreatic cancer.
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
79 years-old >
Gender Male and Female
Key inclusion criteria 1) Age at the date of registration is between 20 and 79 years.
2) Pancreatic cancer has been diagnosed by imaging or cytology/histology.
3) Resectable or Borderline resectable pancreatic cancer has been determined by contrast-enhanced CT or contrast-enhanced MRI, with neoadjuvant chemotherapy planned.
4) The patient with distal bile duct stenosis by pancreatic cancer needs biliary drainage*.
T-Bil>1.5mg/dL, AST>100U/L or ALT>100U/L.
5) No endoscopic transpapilary biliary drainage with plastic stent, Endoscopic nasobiliary drainage, or FCSEMS was performed.
*Int patients with a history of percutaneous biliary drainage, the patient was eligible if 5) was met.
6) Major organ functions are preserved.
7) Performance status is kept at 0 and 1.
8) Written informed consent.
Key exclusion criteria 1) The patient has acute cholangitis.
2) Duodenal stenosis is suspected on specific symptoms or imaging studies.
3) The physician determines that the patient's enrollment in the study is inappropriate.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Takuji
Middle name
Last name okusaka
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology Division
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL 03-3542-2511
Email tokusaka@ncc.go.jp

Public contact
Name of contact person
1st name Shota
Middle name
Last name Harai
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology Division
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email shotaharai02@gmail.com

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
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 National Cancer Center Hospital
Address 5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
Tel 03-3542-2511
Email shotaharai02@gmail.com

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 07 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 08 Month 27 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 04 Month 30 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 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047585

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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