Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation

Naval Military Medical University

Status and phase: Unknown; Phase 3

Conditions: Bile Duct Diseases; Endoscopic Retrograde Cholangiopancreatography

Treatments: Procedure: Precut papillotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01745978

changhai-121202

Details and patient eligibility

About

The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.

Full description

Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation following the failure of conventional bile duct cannulation. Needle knife papillotomy is the most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. Due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists.

The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. Since the process of precut papillotomy is similar to ESD, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and safety of this instrument in precut papillotomy have not been reported. We therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult CBD cannulation.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• intact papilla and deep cannulation of the bile duct
• a standard wire-guided cannulation >10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5

Exclusion criteria

• ampullary tumors
• Billroth II or Roux-en-Y anatomy
• prior endoscopic sphincterotomy(EST) or biliary stent
• choledochoduodenal fistulae

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

the knob-tipped knife

Experimental group

Description:

the knob-tipped knife using for precut papillotomy in difficult CBD cannulation

Treatment:

Procedure: Precut papillotomy

the needle knife

Active Comparator group

Description:

the needle knife using for precut papillotomy in difficult CBD cannulation

Treatment:

Procedure: Precut papillotomy