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prospective study on the relevance of Ringer's solution loading for prevention of Post-ERCP Pancreatitis

prospective study on the relevance of Ringer's solution loading for prevention of Post-ERCP Pancreatitis - RESOLUTION-PEP study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041564
Enrollment
200
Registered
2020-08-26
Start date
2020-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatitis

Interventions

The bolus of Ringer&#39
s solution is administered at 5 ml/kg at the same time as the start of ERCP, and the Ringer&#39
s solution is administered at 3 ml/kg/h for 8 hours after ERCP.

Sponsors

Mie University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the incidence of post-ERCP pancreatitis.

Secondary

MeasureTime frame
Secondary endpoints include PEP severity, and hydration-related complications.

Countries

Japan

Contacts

Public ContactReiko Yamada

Mie University Hospital Gastroenterology and Hepatology

reiko-t@clin.medic.mie-u.ac.jp059-231-5017

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026