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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034578
Receipt No. R000039416
Scientific Title A single-facility prospective study for the effectiveness of endoscopic pancreatic duct stenting for gallstones pancreatitis and post-ERCP pancreatitis
Date of disclosure of the study information 2018/10/20
Last modified on 2019/03/31

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Basic information
Public title A single-facility prospective study for the effectiveness of endoscopic pancreatic duct stenting for gallstones pancreatitis and post-ERCP pancreatitis
Acronym PEP-EPS study
Scientific Title A single-facility prospective study for the effectiveness of endoscopic pancreatic duct stenting for gallstones pancreatitis and post-ERCP pancreatitis
Scientific Title:Acronym PEP-EPS study
Region
Japan

Condition
Condition Gallstones pancreatitis, Post-ERCP pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the effective time of endoscopic pancreatic stenting (EPS) for pancreatitis, we measure the time from onset of pancreatitis to the EPS procedure was performed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of golden time of endoscopic intervention for acute obstructive pancreatitis
Key secondary outcomes Measurement of the ratio of stent obstruction when EPS were performed to acute obstructive pancreatitis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Total 30 number of post-ERCP pancreatitis and gallstones pancreatitis patients
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 Gallstones pancreatitis patients and post-ERCP pancreatitis patients
Key exclusion criteria 1. More than 48 hours from the onset of pancreatitis
2. Intraductal papillary mucinous neoplasm (IPMN) patients
3. Patients who did not receive concent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hayasaka Kenji
Organization New Tokyo Hospital
Division name Department of gastroenterology
Zip code
Address 1271 Wanagayaa, Matsudo, Chiba 270-2232 Japan
TEL 81-47-711-8700
Email dr25027@gk2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayasaka Kenji
Organization New Tokyo Hospital
Division name Department of gastroenterology
Zip code
Address 1271 Wanagayaa, Matsudo, Chiba 270-2232 Japan
TEL 81-47-711-8700
Homepage URL
Email dr25027@gk2.so-net.ne.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

Funding Source
Organization Self-funding
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
Address
Tel
Email

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
2018 Year 10 Month 20 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
2018 Year 10 Month 19 Day
Date of IRB
2018 Year 09 Month 11 Day
Anticipated trial start date
2018 Year 10 Month 20 Day
Last follow-up date
2019 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
2018 Year 10 Month 19 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039416

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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