Tailored Hydration for the Prevention of Post-ERCP Pancreatitis
Condition: Cholangiopancreatography, Endoscopic Retrograde; Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      Aggressive hydration of lactated Ringer's solution has shown considerable beneficial effect
      in preventing post-ERCP(endoscopic retrograde cholangiopancreatography) pancreatitis. But the
      occurence rate of post-ERCP pancreatitis are near 10% and there are severe complications of
      aggressive hydration due to hypervolemia such pulmonary and peripheral edema, prolonged
      hospital stay and increased medical expense. Also there are no definite guidelines that
      suggest the duration and amount of hydration.

      This study evaluates the efficacy and safety of tailored hydration depending on each
      patient's condition that indicates the likelihood of developing post-ERCP pancreatitis.
    

Detailed description: 
      ERCP(Endoscopic retrograde cholangiopancreatography) is the gold standard of diagnosis and
      treatment of pancreatobiliary disease. Pancreatitis is the most common complication after
      ERCP and can be lethally fatal.

      The most fundamental modality of preventing and treatment of post-ERCP pancreatitis is
      hydration and recent studies showed considerable preventive effect of aggressive hydration of
      lactated Ringer's solution. Lactated Ringer's solution has very low risk of adverse reaction
      and low cost compared to other preventive modalities such as octreotide, corticosteroids and
      protease inhibitors.

      Despite of these advantages of aggressive hydration of lactated Ringer's solution, the
      occurence rate of post-ERCP pancreatitis is near 10% and severe complications can develop due
      to hypervolemia caused by aggressive hydration such as pulmonary and peripheral edema,
      prolonged hospital stay and increased medical expense. Most of post-ERCP pancreatitis occur
      within several hours after ERCP and outpatients department based ERCP is suggested in some
      clinics by selecting patients with low risk of post-ERCP pancreatitis. A study compared the
      occurrence of post-ERCP pancreatitis between group with early feeding (4 hours after ERCP)
      and group with conventional feeding (24 hours after ERCP) and showed no difference. The most
      sensitive marker for predicting post-ERCP pancreatitis is abdominal pain and the occurrence
      time differs by whether endoscopic retrograde pancreatic duct (ERPD) stent insertion was
      performed or not. Patients without ERPD stent mostly develops abdominal pain at 2 hour after
      ERCP (0.5-2.5 hours) and patients with ERPD stent at 5 hour (0-68 hours). Also elevation of
      serum amylase level above 1.5 times the upper normal range after 4 hours of ERCP was
      suggested as useful marker for prediction of post-ERCP pancreatitis (AUROC 88.2%, 95%
      confidence interval 80.4%-90.6%).

      The effectiveness of hydration for preventing post-ERCP pancreatitis is widely accepted but
      there are no definite guidelines that suggest the duration and amount of hydration.

      Therefore, the purpose of this study is to evaluate the safety and efficacy of tailored
      hydration therapy based on markers that predicts the risk of post-ERCP pancreatitis
      development.
    

Intervention name(s): Tailored aggressive hydration; Tailored standard hydration
Intervention type(s): Drug; Drug
Intervention description(s): Hydration with lactated Ringer's solution with rate of 3.0 milliliter(mL)/kg/hr during and after ERCP and bolus injection of 20mL/kg for 1 hour after ERCP.
At 4 hours after ERCP (patients with ERPD stent insertion ; 6 hours), abdominal pain and serum amylase are checked. If pain (≥ Numeric rating scale (NRS) scale 3) is absent and amylase is below 1.5 times the upper normal limit (UNL), patient starts feeding and stops hydration. If patient has any of these signs, fasting and hydration continues.
At 8 hours, if pain (<NRS scale 3) is absent, patient starts feeding and stops hydration. If patient has pain (≥ NRS scale 3) and previously checked amylase or re-checked serum amylase is above 3 times the UNL, patient is regarded as post-ERCP pancreatitis and receives 3mL/kg hydration. Patient with pain (≥ NRS scale 3) and previously checked serum amylase above 1.5 times but below 3 times the UNL, serum amylase is re-checked.; Hydration with lactated Ringer's solution with rate of 1.5milliliter(mL)/kg/hr during and after ERCP.
At 4 hours after ERCP (patients with ERPD stent insertion ; 6 hours), abdominal pain and serum amylase are checked. If pain (≥ Numeric rating scale (NRS) scale 3) is absent and amylase is below 1.5 times the UNL(upper normal limit), patient starts feeding and stops hydration. If patient has any of these signs, fasting and hydration continues.
At 8 hours, if pain (<NRS scale 3) is absent, patient starts feeding and stops hydration. If patient has pain (≥ NRS scale 3) and previously checked amylase or re-checked serum amylase is above 3 times the UNL, patient is regarded as post-ERCP pancreatitis and receives 3mL/kg hydration. Patient with pain (≥ NRS scale 3) and previously checked serum amylase above 1.5 times but below 3 times the UNL, serum amylase is re-checked.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Endoscopic retrograde pancreatocholangiography; Pancreatitis; Lactate ringer's solution; Tailored therapy