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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046517


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name