Trial of Aggressive Hydration Versus Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a commonly performed endoscopic procedure used to treat pancreato-biliary pathology. Acute pancreatitis or post-ERCP pancreatitis (PEP), is the most common major complication of ERCP, which is reported to occur in 2-10% of patients overall (ranging from 2-4% in low risk patients up to 8-40% in high-risk patients). Hydration is a mainstay of treatment for acute pancreatitis, independent of etiology. Aggressive hydration has also been shown to decrease incidence of PEP. Rectal NSAIDs, including Indomethacin, has a proven role in prevention of PEP. Though both aggressive hydration and rectal indomethacin are efficacious in preventing PEP, there is no head to head trial comparing the efficacy of these two therapeutic modalities. Thus, the aim is to determine whether aggressive intravenous peri-procedural hydration or high dose rectal indomethacin immediately after ERCP decrease the incidence of PEP. The investigator's hypothesis is that prophylactic treatment with aggressive intravenous hydration is not inferior to rectal indomethacin in preventing PEP.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• All patients aged 18 to 70 years undegoingt ERCP for the first time

• Patients undergoing ERCP for standard clinical indications

Exclusion Criteria:

• Ongoing acute pancreatitis

• Known chronic calcific pancreatitis

• Pancreatic head mass

• Any malignancy

• Standard contraindications to ERCP

• Unwillingness or inability to consent for the study

• Ongoing hypotension including those with sepsis

• Cardiac insufficiency (CI, >NYHA Class II heart failure)

• Renal insufficiency (RI, creatinine clearance <40mL/min)

• Severe liver dysfunction (albumin < 3mg/dL)

• Respiratory insufficiency (defined as oxygen saturation < 90%)

• Greater than 70 years of age

• Pregnancy

• Breastfeeding mother

• Allergy/hypersensitivity to aspirin or NSAIDs

• Received NSAIDs in prior 7 days (aspirin 325mg or less ok)

• Active or recurrent (within 4 weeks) gastrointestinal hemorrhage

• Hyponatremia (Na+ levels < 135mEq/L))

• Hypernatremia (Na+ levels > 150mEq/L) will be excluded.

• Edema or anasarca

• Ascites

• Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (dorsal duct not attempted on injected)

• ERCP for biliary stent removal or exchange without anticipated pancreatogram

• Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram

• Anticipated inability to follow protocol