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Recruitment status Completed
Unique ID issued by UMIN UMIN000011516
Receipt No. R000010571
Official scientific title of the study 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

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Basic information
Official scientific title of the study The randomized trial of mixed amino acid medication to prevent post-ERCP pancreatitis
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Takamitsu Sato
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL +81-45-787-2640
Email tasatou-ykh@umin.ac.jp

Public contact
Name of contact person Takamitsu Sato
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL +81-45-787-2640
Homepage URL
Email tasatou-ykh@umin.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010571


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