A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and
      serious complication of ERCP procedures, occurring in approximately 5-15% of unselected
      patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several
      investigations in recent years. Hydration is considered a mainstay of treatment for acute
      pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether
      intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP
      pancreatitis.

      Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo
      diagnostic or therapeutic ERCP will be recruited.

      Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration
      (treatment arm) or standard hydration (standard arm). Randomization will be performed in a
      double blinded fashion using computer-generated random numbers.

      Treatment arm (vigorous hydration arm);

        -  Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP

        -  Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and
           continued for 8 hours.

        -  At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over
           1hour Standard arm (standard hydration arm);

        -  Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids
           will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after
           ERCP.

      The primary endpoint was development of post-ERCP pancreatitis, which define as increased
      pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three
      times the upper limit of normal).

      The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of
      pancreatitis, and fluid overload.
    

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 prevention of post-ERCP pancreatitis has been the topic of several
      investigations in recent years. Hydration is considered a mainstay of treatment for acute
      pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether
      intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP
      pancreatitis.

      Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration
      (treatment arm) or standard hydration (standard arm). Randomization will be performed in a
      double blinded fashion using computer-generated random numbers.

      Treatment arm (vigorous hydration arm);

        -  Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP

        -  Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and
           continued for 8 hours.

        -  At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over
           1 hour

      Standard arm (standard hydration arm);

      - Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids
      will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.

      The primary endpoint is development of post-ERCP pancreatitis, which define as increased
      pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three
      times the upper limit of normal).

      The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of
      pancreatitis, and fluid overload.

      Serum amylase levels are measured at baseline, and at 8 hours and 18-24 hours, 48 hours after
      the procedure.

      Investigators recorded the details of the maneuvers performed, including:

        1. the total time of the procedure,

        2. the number of attempts at cannulation,

        3. the number of pancreatic duct cannulation,

        4. the final diagnosis by ERCP,

        5. whether a sphincterotomy, a needle-knife papillotomy, or stent placement

        6. endoscopic papillary balloon dilation,

        7. common bile duct (C) tissue sampling (biopsy, brush, cytology),

        8. common bile duct-intraductal ultrasonography (C-IDUS),

             -  Serum amylase is determined 8, 18~24, and 48 hours after ERCP.

                  -  If the 12-hours serum amylase level was > 3 times the upper normal limit and
                     the patient exhibited pain or nausea and vomiting, then the patient had
                     pancreatitis.

                  -  Acute pancreatitis is defined as serum amylase > 3 times the upper limit of
                     normal and associated with epigastric pain, back pain, and epigastric
                     tenderness.

             -  Statistical analysis:

                  1. Randomization was done by the GI nurse, concealed envelop

                  2. Data were summarized by descriptive statistics.

                  3. The Chi square was used to compare categorical patient data.

                  4. The Student's t test was used to compare continuous variables.

                  5. Two-tailed P < 0.05 was considered to indicate significance.
    

Intervention name(s): lactated Ringer's solution (vigorous hydration arm); lactated Ringer's solution (standard hydration arm); endoscopic retrograde cholangiopancreatography (ERCP)
Intervention type(s): Drug; Drug; Device
Intervention description(s): Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP
Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours.
At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour; - Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP.; endoscopic retrograde cholangiopancreatography
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: pancreatitis; ERCP