UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013086 |
|---|---|
| Receipt number | 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 00:14:42 |
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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
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
yutakoike1217@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Sapporo City General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015253
