Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
NCT ID: NCT01745978
Last Updated: 2012-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2012-12-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the knob-tipped knife
the knob-tipped knife using for precut papillotomy in difficult CBD cannulation
Precut papillotomy
the needle knife
the needle knife using for precut papillotomy in difficult CBD cannulation
Precut papillotomy
Interventions
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Precut papillotomy
Eligibility Criteria
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Inclusion Criteria
* a standard wire-guided cannulation \>10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5
Exclusion Criteria
* Billroth II or Roux-en-Y anatomy
* prior endoscopic sphincterotomy(EST) or biliary stent
* choledochoduodenal fistulae
18 Years
90 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Director of Gastroenterology
Locations
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Changhai Hospital, Second Military Medical University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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zhaoshen Li, MD
Role: primary
Other Identifiers
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changhai-121202
Identifier Type: -
Identifier Source: org_study_id