UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040745 |
|---|---|
| Receipt number | R000046517 |
| Scientific Title | Examination of loading transfusion with lactated Ringer's solution to prevent post-ERCP pancreatitis: Randomized controlled trial |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/12/15 19:35:17 |
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Basic information
Public title
Examination of loading transfusion to prevent post-ERCP pancreatitis: Randomized controlled trial
Acronym
Effect of post-ERCP pancreatitis by loading fluid
Scientific Title
Examination of loading transfusion with lactated Ringer's solution to prevent post-ERCP pancreatitis: Randomized controlled trial
Scientific Title:Acronym
Post-ERCP pancreatitis prevention effect by lactated Ringer's solution infusion
Region
| Japan |
Condition
Condition
Biliary-pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of preventing post ERCP pancreatitis onset by ensuring a sufficient volume of infusion in all patients who underwent ERCP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-ERCP pancreatitis incidence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Begin the infusion at a maintenance infusion volume of 1.5 ml/kg/h (or 2000 ml/24 h) before the start of ERCP.
Maintenance infusion should be extracellular fluid (lactated Ringer's solution) or maintenance fluid (No. 3 solution).
Add 2 ml/kg/h:8h (or 1000 ml/8h) from the start of ERCP as load infusion.
The content of the infusion solution should be extracellular fluid (lactated Ringer's solution).
When pancreatitis is diagnosed, a large volume of infusion is required for the treatment of acute pancreatitis.
The volume of infusion after 24 hours from ERCP (next day) will be determined by the doctor in charge.
Interventions/Control_2
Begin maintenance infusion at 1.5 ml/kg/h (or 2000 ml/24 h) before the start of ERCP.
Maintenance infusion should be extracellular fluid (lactated Ringer's solution) or maintenance fluid (No. 3 solution).
The normal infusion group, which is the control group, does not perform load infusion.
When pancreatitis is diagnosed, a large volume of infusion is required for the treatment of acute pancreatitis.
The volume of infusion after 24 hours from ERCP (next day) will be determined by the doctor in charge.
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
(1) Patients 20 years or older at the time of consent acquisition
(2) Gender: Any
(3) Patients who are clinically indicated for ERCP and perform ERCP
(4) Post-ERCP pancreatitis risk (moderate or higher)
(5) PS is 2 or less
(6) Patients who can take oral drugs, meals and beverages
(7) Patients expected to have stable primary disease (including cancer) 6 months after registration during the observation period
(8) Patients who can obtain written informed consent for participation in this study, comply with the compliance requirements during this study, receive the medical examination prescribed in this study plan, and report symptoms etc.
Key exclusion criteria
(1) Patients with low risk of post-ERCP pancreatitis (confirmed cases of chronic pancreatitis, pancreatic head tumor, periodic biliary stent replacement)
(2) Patients with acute pancreatitis
(3) Patients with hypotension including sepsis
(4) Heart failure patients (NYHA Class II or above)
(5) Patients with renal failure (creatinine clearance <30 mL/min)
(6) Patients with liver failure (patients with cirrhosis and ascites)
(7) Patients with respiratory failure (defined as oxygen saturation <90%)
(8) Hyponatremia (Na+ levels <130mEq/L)
(9) Hypernatremia (Na+ levels> 150mEq/L)
(10) Hypokalemia (K+ levels <3.0mEq/L)
(11) Patients who are pregnant or breastfeeding, patients who wish to become pregnant during the study period, patients who wish to become pregnant of a partner during the study period.
(12) In addition, patients who are judged to be unsuitable for study participation by the investigator or investigator based on the combination therapy and medical findings.
Target sample size
868
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kurita |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2640
Kurita1023@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kurita |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2640
Homepage URL
kurita1023@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Yokohama City University Next Generation Clinical Research Center
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
Tel
045-370-7933
rinri@yokohama-cu.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
| 2020 | Year | 06 | Month | 15 | 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
| 2020 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046517
