Efficacy of Fistulotomy for Biliary Cannulation

NARecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

July 3, 2019

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
CholangiocarcinomaCholedocholithiasis; CholangitisPancreatic CancerPancreatitis
Interventions
PROCEDURE

Fistulotomy - High experienced.

We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.

PROCEDURE

Fistulotomy - Low experienced.

We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.

PROCEDURE

Conventional (guidewire) cannulation- High experienced

We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.

PROCEDURE

Conventional (guidewire) cannulation - Low experienced

We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.

Trial Locations (1)

06700

RECRUITING

Centro Medico Nacional Siglo XXI Hospital de Especialidades, Mexico City

All Listed Sponsors
lead

Coordinación de Investigación en Salud, Mexico

OTHER_GOV