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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745978
Recruitment Status : Unknown
Verified December 2012 by Zhaoshen Li, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Endoscopic Retrograde Cholangiopancreatography Bile Duct Diseases Procedure: Precut papillotomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : December 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

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

Primary Outcome Measures :
  1. Successful biliary cannulation rate after precut papillotomy [ Time Frame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure ]

Secondary Outcome Measures :
  1. Biliary cannulation time after precut papillotomy [ Time Frame: From precut papillotomy started to biliary cannulation achieved or abandoned ]

Other Outcome Measures:
  1. The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation [ Time Frame: 7 days after ERCP ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745978

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Contact: zhaoshen Li, MD 86-21-81873241
Contact: feng Liu, MD 86-21-81873262

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Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: zhaoshen Li, MD    86-21-81873241   
Principal Investigator: zhaoshen Li, MD         
Sponsors and Collaborators
Changhai Hospital

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Responsible Party: Zhaoshen Li, Director of Gastroenterology, Changhai Hospital Identifier: NCT01745978     History of Changes
Other Study ID Numbers: changhai-121202
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases