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

Bile Duct Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745978
• Other study ID #: changhai-121202
• Status: Recruiting
• Phase: Phase 3
• First received: December 6, 2012
• Last updated: December 7, 2012
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2012
• Source: Changhai Hospital
• Contact: zhaoshen Li, MD
• Phone: 86-21-81873241
• Email: zhaoshenlismmu[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases
• Endoscopic Retrograde Cholangiopancreatography

Intervention

Procedure:
• Precut papillotomy

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation		7 days after ERCP	Yes
Primary	Successful biliary cannulation rate after precut papillotomy		During endoscopic retrograde cholangiopancreatography (ERCP) procedure	No
Secondary	Biliary cannulation time after precut papillotomy		From precut papillotomy started to biliary cannulation achieved or abandoned	No