Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
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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. |
- Successful biliary cannulation rate after precut papillotomy [ Time Frame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure ] [ Designated as safety issue: No ]
- Biliary cannulation time after precut papillotomy [ Time Frame: From precut papillotomy started to biliary cannulation achieved or abandoned ] [ Designated as safety issue: No ]
- 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 |
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| Contact: zhaoshen Li, MD | 86-21-81873241 | zhaoshenlismmu@gmail.com |
| Contact: feng Liu, MD | 86-21-81873262 | drliuffeng@hotmail.com |
| 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 | |
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 June 17, 2013