UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041564 |
|---|---|
| Receipt number | R000047456 |
| Scientific Title | prospective study on the relevance of Ringer's solution loading for prevention of Post-ERCP Pancreatitis |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2023/09/03 14:20:14 |
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Basic information
Public title
prospective study on the relevance of Ringer's solution loading for prevention of Post-ERCP Pancreatitis
Acronym
RESOLUTION-PEP study
Scientific Title
prospective study on the relevance of Ringer's solution loading for prevention of Post-ERCP Pancreatitis
Scientific Title:Acronym
RESOLUTION-PEP study
Region
| Japan |
Condition
Condition
pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted this prospective study with the hypothesis that moderate hydration with lactated Ringer's solution can be an effective strategy for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) with minimal to no risk.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the incidence of post-ERCP pancreatitis.
Key secondary outcomes
Secondary endpoints include PEP severity, and hydration-related complications.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The bolus of Ringer's solution is administered at 5 ml/kg at the same time as the start of ERCP, and the Ringer's solution is administered at 3 ml/kg/h for 8 hours after ERCP.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients over 20 years old
2) Patients who need ERCP
3) Patients who have never received treatment of papilla
4) Those who have obtained informed consent to participate in the research
Key exclusion criteria
1) Patients with heart failure (NYHA II or more)
2) Patients with impaired renal function (eGFR<45mL/min/1.73m2)
3) Patients with respiratory failure (SpO2<90% in room air)
4) Patients with pancreatitis before ERCP
5) Patients with Performance Status >3
6) Patients with colostomy who cannot administer diclofenac sodium intra-rectally
7) Patients contraindicated with diclofenac sodium
8) Patients with postoperative reconstructed tract
9) Patients who cannot reach the papilla due to organic narrowing of the digestive tract
10) Patients who are pregnant or may be pregnant
11) Patients who are determined to be inappropriate for inclusion in the study by the co-investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University Hospital
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
TEL
059-231-5017
reiko-t@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University Hospital
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
TEL
059-231-5017
Homepage URL
reiko-t@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
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
Mie University
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
Tel
059-231-5017
reiko-t@clin.medic.mie-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
| 2020 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
231
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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047456
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