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Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

NCT02346448 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-02-12

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

endoscopic sphincterotomy

sphincterotomy during ERCP

PROCEDURE

balloon dilatation for 3 minutes

balloon dilatation during ERCP using 10mm balloon

PROCEDURE

balloon dilatation for 6 minutes

balloon dilatation during ERCP using 10mm balloon

Sponsors & Collaborators

  • Helios Albert-Schweitzer-Klinik Northeim

    lead OTHER

Principal Investigators

  • Tobias Meister, PDDr.med. · Helios Albert-Schweitzer-Hospital

  • Volker Ellenrieder, ProfDr.med. · University Medical Center Göttingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02346448 on ClinicalTrials.gov