UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034710 |
|---|---|
| Receipt number | R000039565 |
| Scientific Title | 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 | 2019/12/05 17:03:12 |
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Basic information
Public title
Preventive effect of post-ERCP pancreatitis by cooling the duodenal papilla with ice water
Acronym
Ice water challenge
Scientific Title
Preventive effect of post-ERCP pancreatitis by cooling the duodenal papilla with ice water
Scientific Title:Acronym
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 250 ml of cold water.
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 with a history of ERCP
Patient in postoperative reconstructed intestinal tract (Except for billroth-I)
Patients with acute pancreatitis
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
100
Research contact person
Name of lead principal investigator
| 1st name | Shunjiro |
| Middle name | |
| Last name | Azuma |
Organization
Kitano Hospital Tazuke Kofukai Medical Research Institute
Division name
Gastroenterology and hepatology
Zip code
534-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka
TEL
06-6312-1221
s-azuma@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Shunjiro |
| Middle name | |
| Last name | Azuma |
Organization
Kitano Hospital Tazuke Kofukai Medical Research Institute
Division name
Gastroenterology and hepatology
Zip code
534-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka, Japan
TEL
06-6312-1221
Homepage URL
s-azuma@kitano-hp.or.jp
Sponsor or person
Institute
Kitano Hospital Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Kitano Hospital Tazuke Kofukai Medical Research Institute
Address
2-4-20 Ohgimachi, Kita-ku, Osaka city, Osaka, Japan
Tel
06-6312-1221
rinshou@kitano-hp.or.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039565
