Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
Primary Purpose
Endoscopic Retrograde Cholangiopancreatography, Bile Duct Diseases
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Precut papillotomy
Sponsored by
About this trial
This is an interventional treatment trial for Endoscopic Retrograde Cholangiopancreatography
Eligibility 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
Sites / Locations
- Changhai Hospital, Second Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the knob-tipped knife
the needle knife
Arm Description
the knob-tipped knife using for precut papillotomy in difficult CBD cannulation
the needle knife using for precut papillotomy in difficult CBD cannulation
Outcomes
Primary Outcome Measures
Successful biliary cannulation rate after precut papillotomy
Secondary Outcome Measures
Biliary cannulation time after precut papillotomy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01745978
Brief Title
Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
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 Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Retrograde Cholangiopancreatography, Bile Duct Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the knob-tipped knife
Arm Type
Experimental
Arm Description
the knob-tipped knife using for precut papillotomy in difficult CBD cannulation
Arm Title
the needle knife
Arm Type
Active Comparator
Arm Description
the needle knife using for precut papillotomy in difficult CBD cannulation
Intervention Type
Procedure
Intervention Name(s)
Precut papillotomy
Primary Outcome Measure Information:
Title
Successful biliary cannulation rate after precut papillotomy
Time Frame
During endoscopic retrograde cholangiopancreatography (ERCP) procedure
Secondary Outcome Measure Information:
Title
Biliary cannulation time after precut papillotomy
Time Frame
From precut papillotomy started to biliary cannulation achieved or abandoned
Other Pre-specified Outcome Measures:
Title
The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation
Time Frame
7 days after ERCP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhaoshen Li, MD
Phone
86-21-81873241
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
feng Liu, MD
Phone
86-21-81873262
Email
drliuffeng@hotmail.com
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
Phone
86-21-81873241
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
12. IPD Sharing Statement
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Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
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