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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034710
Receipt No. R000039565
Official scientific title of the study Preventive effect of post-ERCP pancreatitis by cooling the duodenal papilla with ice water
Date of disclosure of the study information 2018/12/01
Last modified on 2018/10/30

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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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