Epinephrine, Post-ERCP Acute Pancreatitis
Conditions
Brief summary
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication with high costs, significant morbidity and even mortality. The major mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in preventing PEP. And topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are reports that epinephrine sprayed on the papilla may be effective to prevent PEP. The investigators therefore designed a prospective randomized trial to determine whether routine using papillary epinephrine spraying in patients received octreotide can reduce post-ERCP pancreatitis.
Interventions
PROCEDUREEpinephrine sprayed on the papilla
Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.
PROCEDURESaline sprayed on the papilla
Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ERCP surgery is required 2. Signed inform consent form and agreed to follow-up on time.
Exclusion criteria
1. Acute pancreatitis. 2. Pregnancy or history of allergy to epinephrine. 3. Serious liver, kidney, heart and coagulation disorders 4. Unwilling or inability to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-ERCP pancreatitis in the groups | 48 hours after ERCP | The primary outcome is the incidence of PEP as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc, and 2) amylase or lipase ≥ 3x the upper limit of normal 48 hours after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Others complications | 1 weeks after ERCP | Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al. |
Countries
China
Contacts
Primary ContactMiao Lin
Outcome results
None listed