Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Locations
- 6
- Primary Endpoint
- acute pancreatitis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
endoscopic sphincterotomy
performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome
Intervention: endoscopic sphincterotomy (Procedure)
balloon dilatation for 3 minutes
Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size)
Intervention: balloon dilatation for 3 minutes (Procedure)
balloon dilatation for 6 minutes
Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size)
Intervention: balloon dilatation for 6 minutes (Procedure)
Outcomes
Primary Outcomes
acute pancreatitis
Time Frame: one to 10 days
Definition of acute pancreatitis: Serum lipase or amylase obtained 2 to 6 hours following ERCP + onset of abdominal pain after ERCP persisting for 24h+ need for analgesia
Secondary Outcomes
- severity of pancreatitis using the Imrie score system (according to Imrie et al.)(one to 10 days)
- endoscopic perforation(one to two days)
- major bleeding(one to two days)