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

Not Applicable

• Conditions: Epinephrine; Post-ERCP Acute Pancreatitis
• Interventions: Procedure: Epinephrine sprayed on the papilla; Procedure: Saline sprayed on the papilla

• Registration Number: NCT03756116
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-28
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epinephrine sprayed on the papilla	Epinephrine 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.
Saline sprayed on the papilla	Saline 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; followed by octreotide.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Others complications	1 weeks after ERCP	Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al.

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China