Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Last updated: February 10, 2019
Sponsor: Helios Albert-Schweitzer-Klinik Northeim
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Treatment

N/A

Clinical Study ID

NCT02346448
HELIOS 4/8/14
  • Ages > 18
  • All Genders

Study Summary

One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter.

This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • independent indication for ERCP

  • age ≥ 18 years

  • patient is able to understand informed consent

Exclusion

Exclusion Criteria:

  • S/p sphincterotomy

  • pancreatic or CBD-stent in situ

  • pregnant patient

  • known chronic pancreatitis

  • acute pancreatitis prior to intervention

Study Design

Total Participants: 600
Study Start date:
February 01, 2015
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Department of Gastroenterology, University Medical Center

    Göttingen, Lower Saxony 37075
    Germany

    Active - Recruiting

  • HELIOS Albert-Schweitzer Hospital Northeim

    Northeim, Lower Saxony 37154
    Germany

    Active - Recruiting

  • HELIOS Klinikum Erfurt

    Erfurt, Thuringia 99089
    Germany

    Active - Recruiting

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