UMIN-CTR Clinical Trial

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