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

NCT03756116 | Unknown DMC

• 1 other identifier: PEP-17-07
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Acute Pancreatitis; Epinephrine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Others complications

  1 weeks after ERCP

Study Arms (2)

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.

Procedure: Epinephrine sprayed on the papilla

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.

Procedure: Saline sprayed on the papilla

Interventions

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.

Epinephrine sprayed on the papilla

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.

Saline sprayed on the papilla

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ERCP surgery is required
• Signed inform consent form and agreed to follow-up on time.

You may not qualify if:

• Acute pancreatitis.
• Pregnancy or history of allergy to epinephrine.
• Serious liver, kidney, heart and coagulation disorders
• Unwilling or inability to provide consent

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Study Officials

• Miao Lin

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao Lin

CONTACT

086-25-58509932; miaolinxh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 28, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 28, 2018

Record last verified: 2018-10

Locations

CN (1)