Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Helios Albert-Schweitzer-Klinik Northeim

Status: Unknown

Conditions: Pancreatitis

Treatments: Procedure: balloon dilatation for 3 minutes; Procedure: endoscopic sphincterotomy; Procedure: balloon dilatation for 6 minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT02346448

HELIOS 4/8/14

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• independent indication for ERCP
• age ≥ 18 years
• patient is able to understand informed consent

Exclusion criteria

• S/p sphincterotomy
• pancreatic or CBD-stent in situ
• pregnant patient
• known chronic pancreatitis
• acute pancreatitis prior to intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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600 participants in 3 patient groups

endoscopic sphincterotomy

Active Comparator group

Description:

performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome

Treatment:

Procedure: endoscopic sphincterotomy

balloon dilatation for 3 minutes

Active Comparator group

Description:

Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size)

Treatment:

Procedure: balloon dilatation for 3 minutes

balloon dilatation for 6 minutes

Active Comparator group

Description:

Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size)

Treatment:

Procedure: balloon dilatation for 6 minutes