Priventive Effect of Ringer's Solution loading on Post ERCP Pancreatitis A Randomized Controlled Study

JRCT ID: jRCTs041230145

Registered date:06/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases requiring ERCP.
• Date of first enrollment: 06/02/2024
• Target sample size: 780
• Study type: Interventional

Intervention(s)

For infusions from 8 hours before ERCP to the start of ERCP, any type of infusion is acceptable.
It should be administered at a rate not exceeding 1.5 ml/kg/h.

Normal infusion group: Ringer's solution is administered at 1.5 ml/kg/h from the start of ERCP and maintained for 9 hours.
Loading infusion group: At the start of ERCP, 500 ml of Ringer's solution (10 ml/kg for patients weighing less than 50 kg) is administered at 500 ml/h. Then, Ringer's solution is administered at 3 ml/kg/h for 8 hours.

All patients will receive intrarectal diclofenac sodium for analgesia after ERCP (at the end of the procedure - within 30 minutes). Diclofenac sodium is administered at a dose of 50 mg, or 25 mg in patients weighing less than 50 kg or older than 80 years.

For infusions after the completion of the infusion specified by treatment group and up to the blood test for PEP determination, any type of infusion may be used. The dose should be administered at a rate not exceeding 1.5 ml/kg/h.

Outcome(s)

• Primary Outcome: Incidence rate of PEP

Secondary Outcome

Incidence rate of PEP by severity.
Incidence rate of hyperamylasemia.
Incidence of adverse events associated with infusion.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

All of the following criteria must be met in order to participate in this study.
1)Patients over 18 years old.
2)Patients who have provided written consent to participate in the study.
3)Patients requiring examination or treatment by ERCP.

Exclude criteria

Patient who meet any of the following criteria may not participate in this study.
1) Patients who have previously undergone ERCP and have a history of EST or EPBD for major duodenal papilla.
2) Patients with any one of the following criteria 1-3 regarding cardiac function.
1 New York Heart Association (NYHA) cardiac function classification of grade II or higher.
2 Left ventricular ejection fraction <40% on echocardiography.
3 Serum BNP level > 100 pg/ml or serum NT-proBNP > 400 pg/ml.
3) Patients with renal dysfunction (eGFR<60mL/min/1.73square meter).
4) Patients with respiratory failure (SpO2<90% at room air).
5) Patients with pancreatitis already complicated before ERCP.
6) Patients presenting with or suspected of dehydration or septic shock.
7) Patients presenting with hypernatremia (serum Na >147 mEq/L).
8) Patients with ECOG PS (Eastern Cooperative Oncology Group Performance Status) >2.
9) Patients who cannot receive diclofenac sodium intrarectally due to colostomy.
10) Patients for whom diclofenac sodium is contraindicated.
11) Patients with a history of allergy to iodine contrast media.
12) Patient with surgical altered anatomy.
13) Patients who are unable to reach the major duodenal papilla by endoscope due to stenosis of the digestive tract.
14) Patients who are initially scheduled for transpapillary intubation into the biliary or pancreatic ducts with guidewire-assisted insertion via the PTBD puncture route (rendezvous under PTBD) or with guidewire-assisted insertion via the EUS puncture route (rendezvous under EUS).
15) Pregnant or possibly pregnant patients.
16) Patients deemed inappropriate for inclusion in the study by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Yamada Reiko
• Secondary Sponsor: Nakagawa Hayato
• Source(s) of Monetary Support: Mie University hospital clinical reserch scholarship