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

• ClinicalTrials.gov Identifier: NCT03756116
• Recruitment Status: Unknown
• First Posted: November 28, 2018
• Last Update Posted: November 28, 2018
• Sponsor: The Second Hospital of Nanjing Medical University
• Information provided by (Responsible Party): The Second Hospital of Nanjing Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-ERCP Acute Pancreatitis; Epinephrine	Procedure: Epinephrine sprayed on the papilla; Procedure: Saline sprayed on the papilla	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: October 1, 2020
• Estimated Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of post-ERCP pancreatitis in the groups [ Time Frame: 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 :

1. Others complications [ Time Frame: 1 weeks after ERCP ]
   Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Miao Lin; 086-25-58509932; miaolinxh@163.com

Locations

China, Jiangsu

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; Recruiting

Nanjing, Jiangsu, China, 210011

Contact: Lin Miao, MD 086-25-58509932 miaolinxh@163.com

Sponsors and Collaborators

The Second Hospital of Nanjing Medical University

Investigators

• Principal Investigator: Miao Lin; Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

More Information

• Responsible Party: The Second Hospital of Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03756116
• Other Study ID Numbers: PEP-17-07
• First Posted: November 28, 2018
• Last Update Posted: November 28, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Epinephrine; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents