Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
1 other identifier
interventional
600
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 12, 2019
February 1, 2019
4.8 years
January 20, 2015
February 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
severity of pancreatitis using the Imrie score system (according to Imrie et al.)
one to 10 days
endoscopic perforation
one to two days
major bleeding
one to two days
Study Arms (3)
endoscopic sphincterotomy
ACTIVE COMPARATORperforming endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome
balloon dilatation for 3 minutes
ACTIVE COMPARATORBalloon 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
ACTIVE COMPARATORBalloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size)
Interventions
balloon dilatation during ERCP using 10mm balloon
balloon dilatation during ERCP using 10mm balloon
Eligibility Criteria
You may qualify if:
- independent indication for ERCP
- age ≥ 18 years
- patient is able to understand informed consent
You may not qualify if:
- S/p sphincterotomy
- pancreatic or CBD-stent in situ
- pregnant patient
- known chronic pancreatitis
- acute pancreatitis prior to intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Gastroenterology, University Medical Center
Göttingen, Lower Saxony, 37075, Germany
HELIOS Albert-Schweitzer Hospital Northeim
Northeim, Lower Saxony, 37154, Germany
HELIOS Klinikum Erfurt
Erfurt, Thuringia, 99089, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tobias Meister, PDDr.med.
Helios Albert-Schweitzer-Hospital
- STUDY DIRECTOR
Volker Ellenrieder, ProfDr.med.
University Medical Center Göttingen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 27, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
February 12, 2019
Record last verified: 2019-02