This study is designed to learn whether rinsing the papilla with cold water at the end of an ERCP procedure, in addition to standard medicine, can help lower the chance of developing pancreatitis, which is the most common major complication after ERCP.
Native papilla present.
Undergoing ERCP for diagnostic or therapeutic indications.
Able to provide informed consent.
Post-operative reconstructed intestinal tract other than Billroth I reconstruction.
Acute pancreatitis at the time of ERCP.
Chronic pancreatitis.
Pancreatic head cancer with occlusion of the main pancreatic duct.
Parallel
Cold water
Procedure/SurgeryRectal indomethacin plus cold water irrigation
Warm water
Procedure/SurgeryRectal indomethacin plus room-temperature water irrigation
Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups
The incidence of post-ERCP pancreatitis (PEP) is defined according to established consensus criteria as new or worsened abdominal pain persisting for at least 24 hours after ERCP, accompanied by serum amylase or lipase levels ≥3 times the upper limit of normal at approximately 24 hours post-procedure, and necessitating hospital admission or prolongation of planned observation.
Severity of post-ERCP pancreatitis
Severity of post-ERCP pancreatitis will be classified per the Revised Atlanta Classification (mild, moderate, or severe), based on organ failure, its duration, and local or systemic complications, with follow-up through 7 days post-ERCP
Length of Hospital Stay Following ERCP
Total number of days hospitalized from the day of ERCP through Day 7 post-ERCP.
Requirement for Additional Interventions Related to Post-ERCP Pancreatitis
Proportion of participants requiring additional interventions related to post-ERCP pancreatitis, including intensive care unit (ICU) admission or surgical or radiologic intervention.
Incidence of Other ERCP-Related Adverse Events
Proportion of participants experiencing ERCP-related adverse events other than post-ERCP pancreatitis, including bleeding, perforation, cholangitis, or cardiopulmonary complications.
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