Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Pancreatitis Clinical Trial

Official title:

Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346448
• Other study ID #: HELIOS 4/8/14
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Helios Albert-Schweitzer-Klinik Northeim
• Contact: Tobias Meister, PDDr.med.
• Phone: +495551971244
• Email: tobias.meister[@]helios-kliniken.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Procedure:
• endoscopic sphincterotomy
sphincterotomy during ERCP
• balloon dilatation for 3 minutes
balloon dilatation during ERCP using 10mm balloon
• balloon dilatation for 6 minutes
balloon dilatation during ERCP using 10mm balloon

Locations

Country	Name	City	State
Germany	HELIOS Klinikum Erfurt	Erfurt	Thuringia
Germany	Department of Gastroenterology, University Medical Center	Göttingen	Lower Saxony
Germany	HELIOS Albert-Schweitzer Hospital Northeim	Northeim	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Helios Albert-Schweitzer-Klinik Northeim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute 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	one to 10 days
Secondary	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	one to 10 days
Secondary	endoscopic perforation	signs of perforation after ERCP, proven by CT scan or surgery	one to two days
Secondary	major bleeding	any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding	one to two days