PRIMARY NEEDLE KNIFE FISTULOTOMY

CompletedOBSERVATIONAL
Enrollment

400

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Pancreatitis
Interventions
PROCEDURE

Primary Needle Knike Fistulotomy

"After verifying the eligibility of the papillary morphology (excluding flat or diverticular papillae according to Viana's classification), access to the bile duct will be initiated using the primary needle knife fistulotomy technique. After the first contact of the needle knife with the papilla, the endoscopist will have a total of 8 minutes, after which he can change to other cannulation techniques (eg standard cannulation methods through the papillary orifice) or even stop the procedure.~During ERCP all patients will be submitted to PEP prophylaxis with indomethacin. Also as a prophylactic PEP measure a pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct. For the purpose of this study, a dedicated form (attached) will be created with the various variables to be analyzed."

Trial Locations (1)

5301-852

ULS Nordeste, Bragança

All Listed Sponsors
lead

University of Minho

OTHER

NCT06452875 - PRIMARY NEEDLE KNIFE FISTULOTOMY | Biotech Hunter | Biotech Hunter