Trials / Unknown
UnknownNCT02346448
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Helios Albert-Schweitzer-Klinik Northeim · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2019-12-01
- Completion
- 2020-12-01
- First posted
- 2015-01-27
- Last updated
- 2019-02-12
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02346448. Inclusion in this directory is not an endorsement.