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

NCT03756116 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2018-11-28

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • The Second Hospital of Nanjing Medical University

    lead OTHER

Principal Investigators

  • Miao Lin · Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756116 on ClinicalTrials.gov