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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinephrine sprayed on the papilla | Experimental | Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope. |
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| Saline sprayed on the papilla | Active Comparator | Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine sprayed on the papilla | Procedure | Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-ERCP pancreatitis in the groups | 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. | 48 hours after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Others complications | Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation,et al. | 1 weeks after ERCP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miao Lin | Contact | 086-25-58509932 | miaolinxh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Miao Lin | Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210011 | China |
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| Saline sprayed on the papilla | Procedure | Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope. |
|