UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059983 |
|---|---|
| Receipt number | R000068611 |
| Scientific Title | Efficacy and Safety of Clinically Feasible Ringer's Solution-Based Aggressive Hydration for the Prevention of Post-ERCP Pancreatitis: A Multicenter Pilot Single-Arm Trial |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/12/05 01:02:46 |
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Basic information
Public title
A Study to Evaluate the Safety and Effectiveness of Ringer's Solution Hydration for Preventing Pancreatitis After ERCP
Acronym
A Study to Evaluate the Safety and Effectiveness of Ringer's Solution Hydration for Preventing Pancreatitis After ERCP
Scientific Title
Efficacy and Safety of Clinically Feasible Ringer's Solution-Based Aggressive Hydration for the Prevention of Post-ERCP Pancreatitis: A Multicenter Pilot Single-Arm Trial
Scientific Title:Acronym
RAPID-PEP
Region
| Japan |
Condition
Condition
biliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of prophylactic aggressive hydration for post-ERCP pancreatitis (PEP) in a multicenter pilot single-arm study.
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aggressive hydration: On the day of ERCP, administer lactated Ringer's solution or acetate Ringer's solution as a continuous infusion at 2.5 mL/kg/hr for 24 hours. Alternatively, administer a 24-hour continuous infusion of lactated or acetate Ringer's solution in the volume calculated according to the table below.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who require ERCP for diagnosis and/or treatment via a biliary approach
(2) Patients with no history of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD)
(3) Patients aged >18 and <85 years
(4) Patients in whom there is sufficient time between obtaining consent and the start of ERCP to initiate the protocol treatment before ERCP
(5) Patients who provide written informed consent to participate in the study
Key exclusion criteria
(1) Patients who meet any of the following cardiac criteria:
(i) New York Heart Association (NYHA) functional class II or higher
(ii) Serum BNP > 100 pg/mL or serum NT-proBNP > 400 pg/mL
(2) Patients with renal dysfunction (eGFR < 60 mL/min/1.73 m2)
(3) Patients with respiratory failure (SpO2 < 90% on room air)
(4) Patients who already have pancreatitis prior to ERCP
(5) Patients who, before ERCP, require massive fluid infusion because of septic shock or similar conditions
(6) Patients with hypernatremia (serum Na > 147 mEq/L)
(7) Patients with physical findings suggesting fluid overload, such as peripheral edema or pulmonary edema
(8) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) >= 3
(9) Patients who require ERCP via a pancreatic duct approach for diagnostic or therapeutic purposes
(10) Patients with surgically altered gastrointestinal anatomy other than Billroth I reconstruction
(11) Patients in whom papillary access is impossible or expected to be impossible because of organic gastrointestinal stenosis or similar conditions
(12) Pregnant women or women who may be pregnant
(13) Patients whom the principal investigator or subinvestigator judges to be inappropriate for inclusion in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Hospital
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
asakai@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Shirohata |
Organization
Kobe University Hospital
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
Homepage URL
white229@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
7-5-1 Kusunoki-cho, chuo-ku, Kobe, Hyogo
Tel
078-382-5111
white229@med.kobe-u.ac.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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | 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=R000068611
