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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
sphincterotomy during ERCP
balloon dilatation during ERCP using 10mm balloon
balloon dilatation during ERCP using 10mm balloon
Department of Gastroenterology, University Medical Center
Göttingen, Lower Saxony, Germany
RECRUITINGHELIOS Albert-Schweitzer Hospital Northeim
Northeim, Lower Saxony, Germany
RECRUITINGHELIOS Klinikum Erfurt
Erfurt, Thuringia, Germany
RECRUITINGacute pancreatitis
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
Time frame: one to 10 days
severity of pancreatitis using the Imrie score system (according to Imrie et al.)
assessment of severity by Imrie score: mild pancreatitis defined by Imrie score \<3, severe pancreatitis if Imrie score \>=3
Time frame: one to 10 days
endoscopic perforation
signs of perforation after ERCP, proven by CT scan or surgery
Time frame: one to two days
major bleeding
any bleeding events associated with ERCP. Drop of Hemoglobin of \> 2g/dl and signs of bleeding
Time frame: one to two days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.