Pancreatitis
Conditions
Keywords
endoscopic sphincterotomy, balloon dilation, adverse events, pancreatitis, bleeding
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.
Interventions
PROCEDUREendoscopic sphincterotomy
sphincterotomy during ERCP
PROCEDUREballoon dilatation for 3 minutes
balloon dilatation during ERCP using 10mm balloon
PROCEDUREballoon dilatation for 6 minutes
balloon dilatation during ERCP using 10mm balloon
Sponsors
Helios Albert-Schweitzer-Klinik Northeim
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute pancreatitis | 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
| Measure | Time frame | Description |
|---|---|---|
| severity of pancreatitis using the Imrie score system (according to Imrie et al.) | one to 10 days | assessment of severity by Imrie score: mild pancreatitis defined by Imrie score \<3, severe pancreatitis if Imrie score \>=3 |
| endoscopic perforation | one to two days | signs of perforation after ERCP, proven by CT scan or surgery |
| major bleeding | one to two days | any bleeding events associated with ERCP. Drop of Hemoglobin of \> 2g/dl and signs of bleeding |
Countries
Germany
Contacts
Primary ContactTobias Meister, PDDr.med.
Outcome results
None listed