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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bile Duct Diseases; Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Procedure: Precut papillotomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: feng Liu, MD; Phone Number: 86-21-81873262; Email: drliuffeng@hotmail.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital, Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation	7 days after ERCP

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): December 10, 2012
• Last Update Submitted That Met QC Criteria: December 7, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases
• Other Study ID Numbers: changhai-121202