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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy and Safety of Precut Papillotomy Using the Knob-tipped Knife and Needle Knife in Difficult Biliary Cannulation: a Randomized-controlled Trial.

Conditions
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Endoscopic Retrograde Cholangiopancreatography, Bile Duct Diseases

Intervention / Treatment
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* Procedure: Precut papillotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the knob-tipped knife<br>the knob-tipped knife using for precut papillotomy in difficult CBD cannulation | Procedure: Precut papillotomy<br> <br> |
| Active Comparator: the needle knife<br>the needle knife using for precut papillotomy in difficult CBD cannulation | Procedure: Precut papillotomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful biliary cannulation rate after precut papillotomy |  | During endoscopic retrograde cholangiopancreatography (ERCP) procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary cannulation time after precut papillotomy |  | From precut papillotomy started to biliary cannulation achieved or abandoned |