UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011516 |
|---|---|
| Receipt number | R000010571 |
| Scientific Title | The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis |
| Date of disclosure of the study information | 2013/08/19 |
| Last modified on | 2016/05/07 17:41:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis
Acronym
The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis
Scientific Title
The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis
Scientific Title:Acronym
The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis
Region
| Japan |
Condition
Condition
post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the frequency of post-ERCP pancreatitis (PEP) of the high risk patients of PEP by changing the meal to mixed amino acid nutrition before ERCP, and vlidate the efficacy of a dietary factor and amino acid nutrition to prevent PEP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) new abdominal pain.
2) eleuation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after ERCP.
3) extension of hospitalization or medical treatment at least two days.
Key secondary outcomes
adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
mixed amino acid medication
Interventions/Control_2
regular diet
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
"Patient-related risk factors"
1) age younger than 60 years old, 2) female sex, 3) suspected bilialy sphincter of Oddi dysfunction (SOD), 4) history of recurrent pancreatitis, and 5) history of PEP.
"Procedure-related risk factors"1) pancreatography, 2) endoscopic pancreatic sphincterotomy (EST), 3) pre-cut sphincteroromy, 4) difficulty of procerure (> 30 min), 5) dificulty of cannulation (> 6 times or > 15 min), 6) pancreatic tissue sampling, 7) biliary biopsy or brushing cytology, 8) intraductal ultrasonography (IDUS), 9) endoscopic balloon dilatation (EPBD), 10) endoscopic papillectomy (EP), 11) Self-expandable metallic stent (SEMS) placement and 12) trainee involvement in the ERCP.
Key exclusion criteria
1) who we could not achieve informed concent, 2) who we evaluated inappropriate for thos trial, 3) who had poor performance status, 4) were under 20 years old, 5) to who ERCP was not completed, 6) who had acute or active pancreatitis, and 7) who had low risk factors of PEP: a) choronic pancreatitis, b) periodical stent exchange, c) ERC to pancreas divisum, and d) the past history of papilla disposal (ex. EST, EPBD and EP).
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamitsu Sato |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
+81-45-787-2640
tasatou-ykh@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamitsu Sato |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
+81-45-787-2640
Homepage URL
tasatou-ykh@umin.ac.jp
Sponsor or person
Institute
Yokohama City University 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
| 2013 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | 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
| 2013 | Year | 08 | Month | 19 | Day |
Last modified on
| 2016 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010571
