Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

June 21, 2022

Study Completion Date

October 11, 2022

Conditions
Biliary DiseaseCommon Bile Duct CalculiBiliary StrictureMalignant Hepatobiliary NeoplasmPancreatic Disease
Interventions
PROCEDURE

PA-EMR

Standard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife.

PROCEDURE

NKF

The needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible.

Trial Locations (1)

81620

Duzce University School of Medicine, Düzce

All Listed Sponsors
collaborator

Cukurova University

OTHER

lead

Duzce University

OTHER