UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047528 |
|---|---|
| Receipt number | R000053209 |
| Scientific Title | Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: a multicenter, single-blinded, randomised controlled trial. |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2024/02/17 00:46:26 |
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Basic information
Public title
Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: a multicenter, single-blinded, randomised controlled trial.
Acronym
EUTOPIA study
Scientific Title
Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: a multicenter, single-blinded, randomised controlled trial.
Scientific Title:Acronym
EUTOPIA study
Region
| Japan |
Condition
Condition
pancreaticobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of ice water injection toward the papilla on the incidence on post-endoscopic retrograde pancreatography (ERCP) pancreatitis (PEP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PEP incidence
Key secondary outcomes
(1) Incidence of PEP in patients with difficult bile duct or pancreatic duct intubation, (2) Incidence of PEP by various ERCP procedures (bile duct purpose, pancreatic duct purpose, EST, EPBD, biopsy, IDUS, bile duct stenting, etc.), (3) Incidence of PEP by presence or absence of pancreatic duct cannulation or pancreatography, (4) Incidence of PEP by cannulation time, ( (5) Severity of PEP, (6) Incidence of PEP by high risk factors for PEP, (7) Incidence of other complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
ice water group
ERCP will be performed, and at the end of the procedure, ice water will be injected on the duodenal papilla. A total of 250 ml is injected five times with a 50 ml syringe. The water in the duodenum is aspirated after each injection, and the scope is removed without aspiration only for the last injection.
Physical examination and blood test will be performed the next morning. Blood tests and abdominal symptoms will be used to determine the presence of PEP and other complications.
Interventions/Control_2
control group
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
The inclusion criteria are applied to patients who were scheduled to undergo an ERCP.
Key exclusion criteria
(1) evaluated 4 levels according to the Eastern Cooperative Oncology Group Performance Status
(2) age younger than 20 years
(3) not native papilla
(4) those cases that were expected to have duodenal papilla that were inaccessible by endoscopy
(5) case of post gastrectomy (excluding B-I reconstruction)
(6)presence of acute pancreatitis
(7) presence of chronic pancreatitis
(8) presence of pancreatic head cancer with occlusion of the main pancreatic duct
(9)inability to provide written informed consent
(10)subjects deemed inappropriate for the trial
Target sample size
880
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kurita |
Organization
Rakuwakai Otowa Hospital
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Department of Gastroenterology and Hepatology
Zip code
607-8062
Address
2 Otowachinjicho Yamashina-ku, Kyoto, 607-8062, Japan
TEL
075-593-4111
kuritaaki1976@gmail.com
Public contact
Name of contact person
| 1st name | Shunjiro |
| Middle name | |
| Last name | Azuma |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Department of Gastroenterology and Hepatology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, 530-8480, 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
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Profit organization
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, 530-8480, Japan
Tel
06-6312-1221
s-azuma@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
| 2022 | Year | 04 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053209
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
