Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
NCT ID: NCT02346448
Last Updated: 2019-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
600 participants
INTERVENTIONAL
2015-02-28
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis
NCT02668081
SpHincterotomy for Acute Recurrent Pancreatitis
NCT03609944
ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP
NCT02830984
Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy
NCT01238341
Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
NCT05061680
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
endoscopic sphincterotomy
performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome
endoscopic sphincterotomy
sphincterotomy during ERCP
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 3 minutes
balloon dilatation during ERCP using 10mm balloon
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)
balloon dilatation for 6 minutes
balloon dilatation during ERCP using 10mm balloon
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age ≥ 18 years
* patient is able to understand informed consent
Exclusion Criteria
* pancreatic or CBD-stent in situ
* pregnant patient
* known chronic pancreatitis
* acute pancreatitis prior to intervention
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helios Albert-Schweitzer-Klinik Northeim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tobias Meister, PDDr.med.
Role: STUDY_DIRECTOR
Helios Albert-Schweitzer-Hospital
Volker Ellenrieder, ProfDr.med.
Role: STUDY_DIRECTOR
University Medical Center Göttingen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jens Scharf, Professor
Role: primary
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HELIOS 4/8/14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.