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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Changhai Hospital
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01745978
First received: December 6, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Endoscopic Retrograde Cholangiopancreatography
Bile Duct Diseases
Procedure: Precut papillotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • Successful biliary cannulation rate after precut papillotomy [ Time Frame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biliary cannulation time after precut papillotomy [ Time Frame: From precut papillotomy started to biliary cannulation achieved or abandoned ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation [ Time Frame: 7 days after ERCP ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745978

Contacts
Contact: zhaoshen Li, MD 86-21-81873241 zhaoshenlismmu@gmail.com
Contact: feng Liu, MD 86-21-81873262 drliuffeng@hotmail.com

Locations
China
Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: zhaoshen Li, MD    86-21-81873241    zhaoshenlismmu@gmail.com   
Principal Investigator: zhaoshen Li, MD         
Sponsors and Collaborators
Changhai Hospital
  More Information

No publications provided

Responsible Party: Zhaoshen Li, Director of Gastroenterology, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01745978     History of Changes
Other Study ID Numbers: changhai-121202
Study First Received: December 6, 2012
Last Updated: December 7, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014