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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01745978
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography; Bile Duct Diseases	Procedure: Precut papillotomy	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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.
• Study Start Date: Dec 1, 2012
• Anticipated Primary Completion Date: Jun 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Successful biliary cannulation rate after precut papillotomy [During endoscopic retrograde cholangiopancreatography (ERCP) procedure]

Secondary Outcome Measures

1. Biliary cannulation time after precut papillotomy [From precut papillotomy started to biliary cannulation achieved or abandoned]

Other Outcome Measures

1. The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation [7 days after ERCP]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital, Second Military Medical University	Shanghai		China	200433

Sponsors and Collaborators

• Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhaoshen Li, Director of Gastroenterology, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT01745978
• Other Study ID Numbers: changhai-121202
• First Posted: Dec 10, 2012
• Last Update Posted: Dec 10, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Bile Duct Diseases

Study Results

No Results Posted as of Dec 10, 2012