Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Not Applicable

• Conditions: Pancreatitis
• Interventions: Procedure: endoscopic sphincterotomy; Procedure: balloon dilatation for 3 minutes; Procedure: balloon dilatation for 6 minutes

• Registration Number: NCT02346448
• Lead Sponsor: Helios Albert-Schweitzer-Klinik Northeim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-24
• Study First Posted: 2015-01-27
• Study Start: 2015-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
endoscopic sphincterotomy	endoscopic sphincterotomy	performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome
balloon dilatation for 3 minutes	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)
balloon dilatation for 6 minutes	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Department of Gastroenterology, University Medical Center; 🇩🇪 Göttingen, Lower Saxony, Germany

HELIOS Albert-Schweitzer Hospital Northeim; 🇩🇪 Northeim, Lower Saxony, Germany

HELIOS Klinikum Erfurt; 🇩🇪 Erfurt, Thuringia, Germany