Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide

Nanjing Medical University

Status: Unknown

Conditions: Epinephrine; Post-ERCP Acute Pancreatitis

Treatments: Procedure: Saline sprayed on the papilla; Procedure: Epinephrine sprayed on the papilla

Study type: Interventional

Funder types: Other

Identifiers

NCT03756116

PEP-17-07

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,000 participants in 2 patient groups

Epinephrine sprayed on the papilla

Experimental group

Description:

Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.

Treatment:

Procedure: Epinephrine sprayed on the papilla

Saline sprayed on the papilla

Active Comparator group

Description:

Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide.

Treatment:

Procedure: Saline sprayed on the papilla