- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745978
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: feng Liu, MD
- Phone Number: 86-21-81873262
- Email: drliuffeng@hotmail.com
Study Locations
-
-
-
Shanghai, China, 200433
- Recruiting
- Changhai Hospital, Second Military Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
|
Active Comparator: the needle knife
the needle knife using for precut papillotomy in difficult CBD cannulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Successful biliary cannulation rate after precut papillotomy
Time Frame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure
|
During endoscopic retrograde cholangiopancreatography (ERCP) procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biliary cannulation time after precut papillotomy
Time Frame: From precut papillotomy started to biliary cannulation achieved or abandoned
|
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
Time Frame: 7 days after ERCP
|
7 days after ERCP
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- changhai-121202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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