UMIN-CTR Clinical Trial

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
Email	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
Email	kurita1023@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046517