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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Sublingual Nitroglycerin: A Multi-center, Single-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03756116
• Other study ID #: PEP-17-07
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2018
• Source: The Second Hospital of Nanjing Medical University
• Contact: Miao Lin
• Phone: 086-25-58509932
• Email: miaolinxh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epinephrine
• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Procedure:
• 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
Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Others complications	Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation,et al.	1 weeks after ERCP