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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013086
Receipt No. R000015253
Scientific Title Direct Spraying of MINCLEA on the Duodenal Papilla for Preventing Post-ERCP Pancreatitis
Date of disclosure of the study information 2014/02/06
Last modified on 2014/02/06

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Basic information
Public title Direct Spraying of MINCLEA on the Duodenal Papilla for Preventing Post-ERCP Pancreatitis
Acronym Direct Spraying of MINCLEA on the Duodenal Papilla for Preventing Post-ERCP Pancreatitis
Scientific Title Direct Spraying of MINCLEA on the Duodenal Papilla for Preventing Post-ERCP Pancreatitis
Scientific Title:Acronym Direct Spraying of MINCLEA on the Duodenal Papilla for Preventing Post-ERCP Pancreatitis
Region
Japan

Condition
Condition post-ERCP pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of direct splaying MINCLEA on duodenal papilla in prevention of post-ERCP pancreatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence rate of post-ERCP pancreatitis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 MINCLEA group sprays MINCLEA on duodenal papilla directly after ERCP.
Interventions/Control_2 Placebo group sprays physiological saline on duodenal papilla directly after ERCP.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who are planned to perform ERCP for further evaluation or treatment.
2) Written informed consent is obtained from patient before the study.
Key exclusion criteria 1) Patients with hypersensitivity to MINCLEA.
2) Patients with a history of EST and EPBD.
3) Patients with receiving endoscopic therapy of ENBD, ENPD, biliary stent or pancreatic stent.
4) Patients with acute pancreatitis.
5) Patients with chronic pancreatitis.
6) Patients with divism or pancreaticobiliary maljunction
7) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Nishikawa
Organization Sapporo City General Hospital
Division name Department of Gastroenterology
Zip code
Address Kita 13 Nishi 11 1-1, Tyuou-ku, Sapporo, Japan
TEL 011-726-2211
Email yutakoike1217@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuta Koike
Organization Sapporo City General Hospital
Division name Department of Gastroenterology
Zip code
Address Kita 13 Nishi 11 1-1, Tyuou-ku, Sapporo, Japan
TEL 011-726-2211
Homepage URL
Email yutakoike1217@gmail.com

Sponsor
Institute Department of Gastroenterology, Sapporo City General Hospital
Institute
Department

Funding Source
Organization None
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
2014 Year 02 Month 06 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
2014 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 06 Day
Last modified on
2014 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015253

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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