UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effect of post-ERCP pancreatitis by cooling the duodenal papilla with ice water
Title of the study (Brief title)	Ice water challenge
Region	Japan

Condition
Condition	Gallbladder cancer / bile duct cancer / pancreatic cancer / bile duct stone / cholangitis / pancreatitis / pancreatic cyst / pancreatic duct stenosis / biliary dilatation etc.
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether to reduce the incidence of post-ERCP pancreatitis by cooling the papilla with ice water after ERCP.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of post-ERCP pancreatitis
Key secondary outcomes	Patient background (age, sex, past history of pancreatitis, PS, ASA, drinking history, smoking history etc.). Presence or absence of cholangitis before treatment. PEP incidence rate due to differences in ERCP procedures (bile duct obesity, pancreatic ductal purpose, EST, EPBD, biopsy, IDUS, biliary stent, pancreatic duct stent, etc.). PEP incidence rate with or without pancreatic ductal intubation/ ductography. PEP incidence rate due to bile duct intubation time. Increase frequency and degree of pancreatic enzyme and inflammatory reaction (WBC, CRP) after 2 hours of ERCP/ next day in the above items. The degree of PEP in the above items.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Before ending with ERCP, ice water is injected endoscopically into the lower duodenum to cool the duodenal papilla. Injection method uses a jet water pump, inject 500 ml of cold water (about one and a half minutes).
Interventions/Control_2
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	ERCP can be enforced, there is no history of nipple treatment was enforced. The age at registration is over 20 years old. After getting enough explanation about participation in research, with sufficient understanding, written consent was obtained from the research subject himself / herself by the free will of the person him / herself.
Key exclusion criteria	Patient after papilla treatment Patient in postoperative reconstructed intestinal tract Patients with pancreatitis or pancreatic enzyme elevation (more than 3 times higher than normal upper limit) before ERCP Patients who require drinking restriction due to heart failure etc. Patients who are judged inappropriate for the research director or the attending physician to conduct this study
Target sample size	600

Research contact person
Name of lead principal investigator	Shunjiro Azuma
Organization	Kitano Hospital Tazuke Kofukai Medical Research Institute
Division name	Gastroenterology and hepatology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka
TEL	06-6312-1221
Email	s-azuma@kitano-hp.or.jp

Public contact
Name of contact person	Shunjiro Azuma
Organization	Kitano Hospital Tazuke Kofukai Medical Research Institute
Division name	Gastroenterology and hepatology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka, Japan
TEL	06-6312-1221
Homepage URL
Email	s-azuma@kitano-hp.or.jp

Sponsor
Institute	Kitano Hospital Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization	Self funding
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	2018 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 12 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 31 Day
Last modified on	2018 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039565

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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