UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056172 |
|---|---|
| Receipt number | R000064186 |
| Scientific Title | Utility and safety of spiral covered self-expanding metallic stent for malignant distal biliary obstruction in unresectable pancreatic cancer: A multi-center single arm pilot study |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/05/18 09:22:56 |
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Basic information
Public title
Utility and safety of spiral covered self-expanding metallic stent for malignant distal biliary obstruction in unresectable pancreatic cancer: A multi-center single arm pilot study
Acronym
study of SCSEMS for Obstruction in Pancreatic cancer Endoscopic procedure; SCOPE study
Scientific Title
Utility and safety of spiral covered self-expanding metallic stent for malignant distal biliary obstruction in unresectable pancreatic cancer: A multi-center single arm pilot study
Scientific Title:Acronym
study of SCSEMS for Obstruction in Pancreatic cancer Endoscopic procedure; SCOPE study
Region
| Japan |
Condition
Condition
malignant distal biliary obstruction in unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is assess the utility and safety of novel self-expanding metal stents for unresectable malignant distal biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of acute cholecystitis within 30 days of stent placement
Key secondary outcomes
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
A fully covered self-expandable metallic stent (FCSEMS) "HILZO STENTS Biliary Covered Stent (Spiral Cover Double Head)" is placed across the papilla through endoscopic retrograde cholangiopancreatography (ERCP)-related techniques.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patient is 18 years of age or older at the time of obtaining consent.
2.The patient has been diagnosed with pancreatic cancer through imaging, cytology, or histology.
3.The patient is deemed unsuitable for surgical resection due to tumor stage or surgical risk.
4.The patient's performance status (PS) is 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale.
5.The patient has provided written informed consent to participate in the trial.
Key exclusion criteria
1.Presence of bile duct stricture that requires the placement of a stent in the hilar or intrahepatic bile ducts.
2.History of cholecystectomy (gallbladder removal).
3.Surgical reconstruction with a non-Billroth I technique (postoperative gastrointestinal reconstruction other than Billroth I).
4.Diagnosis or suspicion of duodenal stenosis based on symptoms or imaging findings.
5.History of bile duct metal stent placement.
6.Preoperative diagnosis of acute cholecystitis or acute pancreatitis.
7.Liver failure where bile duct drainage is unlikely to decrease total bilirubin levels below 3 mg/dL.
8.Other conditions where the physician deems participation in the trial inappropriate for any reason.
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0071
Address
7-5-1 Kusunoki-cho, chuo-ku, Kobe, Hyogo
TEL
078-382-5774
asakai@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Shirohata |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0071
Address
7-5-1 Kusunoki-cho, chuo-ku, Kobe, Hyogo
TEL
078-382-5774
Homepage URL
white229@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
-
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
-
Address
-
Tel
-
-
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
| 2025 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064186
