Feasibility Study of a Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Acute Pancreatitis
Study Overview
Brief Summary
- ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder removal.
- Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable suffering and cost.
- Patients with acute pancreatitis are treated with fluids.
- Our aim is to assess whether prophylactic treatment with aggressive intravenous hydration prevents ERCP pancreatitis.
- In a blinded fashion patients will be randomized to aggressive intravenous versus moderate hydration during and aftere ERCP for standard clinical indications.
Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects against ERCP pancreatitis.
Detailed Description
1.0 BACKGROUND AND HYPOTHESES
Post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is defined as the development of epigastric pain radiating to the back accompanied by either an increase in the pancreatic enzymes (amylase and lipase) to greater than three times the upper limit of normal or cross sectional imaging showing inflammation of the gland. Based on length of hospitalization it is categorized as mild (2-3 days), moderate (4-10 days), or severe (>10 days). Cases complicated by hemorrhage, pseudocyst, phlegmon formation or requiring percutaneous intervention or surgery are also scored as severe.
Post ERCP pancreatitis is the leading complication of biliary endoscopic procedures and could potentially lead to considerable morbidity. The overall incidence of ERCP pancreatitis ranges from 5% in the community to 15% in centers where advanced ERCP including pancreatic interventions are performed.
Proposed mechanisms include protease and free radical mediated inflammation, abnormal sphincter of oddi pressure, and elevated pancreatic exocrine activity. Measures to prevent post-ERCP pancreatitis aim to curb these processes.
Numerous trials studying the use of various preventive therapies including octreotide and protease inhibitors have been for the most part disappointing. There have been more than twenty clinical trials examining the efficacy of somatostatin and octreotide which inhibit pancreatic exocrine stimulation. A meta-analysis of nine high quality trials of somatostatin showed that overall the medication did not reduce post ERCP pancreatitis. Gabexylate mesylate and ulnistatin which inhibit pancreatic proteases have also shown to not significantly reduce post ERCP pancreatitis. Numerous studies have also shown that corticosteroids do not diminish the likelihood of post-ERCP pancreatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All Inpatients aged 18 to 70 years undergoing ERCP for the first time
- •Patients undergoing ERCP for standard clinical indications
Exclusion Criteria
- •Ongoing acute pancreatitis
- •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
- •Hyponatremia (Na+ levels < 135mEq/L))
- •Hypernatremia (Na+ levels > 150mEq/L) will be excluded.
- •Edema or anasarca
Outcomes
Primary Outcomes
Acute Pancreatitis
Time Frame: 24 hours
The primary endpoint is post ERCP pancreatitis which is defined as increased abdominal pain and a serum amylase level three times the upper limit of normal (3xULN). Increased pain will be defined as an increase in the visual analog pain score compared to the value immediately prior to ERCP
Secondary Outcomes
- Serum amylase three times the upper limit of normal(24 hours)
- Increased abdominal pain(24 hours)
- Clinical volume overload(24 hours)
Investigators
James Buxbaum
Director of Endoscopy, University of Southern California
University of Southern California