Status:
COMPLETED
A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
Lead Sponsor:
Dankook University
Collaborating Sponsors:
Wonkwang University
University of Ulsan
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic...
Detailed Description
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic...
Eligibility Criteria
Inclusion
- consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited
Exclusion
- Patients will be excluded if they have acute pancreatitis during the 2 weeks before ERCP, a history of chronic pancreatitis, previous sphincterotomy, or if they refuse to participate the study protocol. Patients will be also excluded if they undergo ERCP, for procedures such as stone removal following previous sphincterotomy, change or removal of previous biliary stents, or surveillance biopsy after endoscopic papillectomy without pancreatography, which are considered to carry minimal risks of post-ERCP pancreatitis. Patients with high risk of fluid overload (heart failure, more than NYHA II; renal insufficiency, creatinine clearance \<40ml/min; liver cirrhosis; or hypoxemia, SaO2 \<90%; signs of pulmonary edema) are excluded.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT02308891
Start Date
November 1 2014
End Date
June 1 2016
Last Update
August 5 2016
Active Locations (3)
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1
Dankook University College of Medicine
Cheonan, Chungcheongnam-do, South Korea, 330-715
2
Wonkwang University
Iksan, Jeollabukdo, South Korea
3
University of Ulsan, Ulsa University Hospital
Ulsan, South Korea