KCT0008359
Recruiting
未知
Aggressive hydration with lactated Ringer’s solution versus Plasma solution for the prevention of post ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis : Multicenter, Double blind, Randomized controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Asan Medical Center
- Enrollment
- 844
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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