Status:
UNKNOWN
Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone
Lead Sponsor:
University of Minho
Collaborating Sponsors:
Unidade Local de Saúde do Alto Minho
Conditions:
Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)
Detailed Description
1. Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced procedure which is widely used in the diagnosis and treatment of a variety of benign and malignant pancreatobil...
Eligibility Criteria
Inclusion
- From June 1, 2020 to June 1, 2022, all individuals referred for ERCP in the Digestive Endoscopy Unit of Santa Luzia Hospital (Unidade Local de Saúde do Alto Minho) will be invited to participate in the study.
- ERCP with indication for biliary access
- Naïve papilla
Exclusion
- Flat papillas
- Intradiverticular / Diverticular border papillas
- Patients unable to sign or understand the informed consent
- Patients with surgically altered anatomy
- Patients with tumors of the papilla
- Previous sphincterotomy
- Spontaneous papillary fistula
- Papilla not visualized
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT04492137
Start Date
June 1 2020
End Date
June 30 2022
Last Update
August 16 2021
Active Locations (1)
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1
Santa Luzia Hospital, ULS Alto Minho
Viana do Castelo, Portugal, 4904-858