Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

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

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 Overview

• Status: Unknown
• Conditions: Pancreatitis
• Intervention / Treatment: Procedure: endoscopic sphincterotomy; Procedure: balloon dilatation for 3 minutes; Procedure: balloon dilatation for 6 minutes

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Recruiting
      • Department of Gastroenterology, University Medical Center
    • Northeim, Lower Saxony, Germany, 37154
      • Recruiting
      • HELIOS Albert-Schweitzer Hospital Northeim
  • Thuringia
    • Erfurt, Thuringia, Germany, 99089
      • Recruiting
      • Helios Klinikum Erfurt
      • Contact: Jens Scharf, Professor
      • Contact: Phone Number: +49361 7810; Email: jens-gerd.scharf@helios-kliniken.de
      • Principal Investigator: Jens Scharf, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: endoscopic sphincterotomy; performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome	Procedure: endoscopic sphincterotomy; sphincterotomy during ERCP
ACTIVE_COMPARATOR: 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)	Procedure: balloon dilatation for 3 minutes; balloon dilatation during ERCP using 10mm balloon
ACTIVE_COMPARATOR: 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)	Procedure: balloon dilatation for 6 minutes; balloon dilatation during ERCP using 10mm balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
endoscopic perforation	signs of perforation after ERCP, proven by CT scan or surgery	one to two days
major bleeding	any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding	one to two days

Collaborators and Investigators

• Sponsor: Helios Albert-Schweitzer-Klinik Northeim
• Investigators: Study Director: Tobias Meister, PDDr.med., Helios Albert-Schweitzer-Hospital; Study Director: Volker Ellenrieder, ProfDr.med., University Medical Center Göttingen

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 24, 2015
• First Posted (ESTIMATE): January 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: bleeding; adverse events; pancreatitis; endoscopic sphincterotomy; balloon dilation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Pancreatitis; Dilatation, Pathologic
• Other Study ID Numbers: HELIOS 4/8/14