Aggressive hydration with lactated Ringer’s solution versus Plasma solution for the prevention of post ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008359
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 844
Intact major papilla in patients with preserved papilla due to non-ERCP Enroll patients who agree to clinical trials if they are at average ~ high risk of pancreatitis (if one or more of the following items applies) after endoscopic retrograde cholangiopancreatography
1.40 years of age or younger
2.(Suspected) Sphincter of oddi dysfunction
3.The normal level of serum total bilirubin
4.History of recurrent pancreatitis
5.Require injection of a contrast agent into the pancreatic duct
6.Require endoscopic biliary or pancreatic sphincterotomy
7.Require precut sphincterotomy
8.Require endoscopic papillary balloon dilation
9.Planned endoscopic papillectomy
10.Diagnosed with periampullary tumor and planned for insertion of a self-expanding metal stent
Exclusion criteria for research subjects : Exclude any of the following items if applicable.
1.Not consented to study participation
2.18 years of age or younger
3.Severe comorbidities (e.g., end-stage kidney disease, end-stage chronic obstructive pulmonary disease, hypoglycemic dysregulation, decompensated liver cirrhosis)
4.Sepsis (defined as meeting two or more of the following items):
v Body temperature >38.3ºC or <36ºC
v Heart rate >90 beats/min
v Tachypnea (respiratory rate > 20 breaths/min)
v Leukocytosis (WBC >12,000 /uL) or leukopenia (WBC <4000 /uL)
5.Acute pancreatitis
6.Chronic pancreatitis
7.Heart failure (NYHA class 2 or higher)
8.Clinical signs of fluid overload
9.Hypernatremia (>150 mEq/L) or hyponatremia (<130 mEq/L)
10. History of endoscopic sphincterotomy
11. History of endoscopic papillary (balloon) dilation
12. Hypercalcemia or alkalemia
13. Scheduled for regular endoscopic biliary stent change
14. Patients with pancreatic head tumors and a presumed low risk for PEP
15. Lack of access to the major duodenal papilla due to surgically altered anatomy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of pancreatitis after ERCP
- Secondary Outcome Measures
Name Time Method Occurrence of presumed PEP;Clinical signs of fluid overload;Hyperamylasemia;Occurrence or aggravation of upper abdominal pain;Days of ERCP-related hospital stay