Clinical Trial: Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial of Short Versus Long Wire and Small Versus Standard Sphincterotomes for Initial Biliary Cannulation

Brief Summary:

1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer.
2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannulation is the most difficult part of the endoscopic retrograde cholangiography (ERCP).
3. New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages.
4. At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care.
5. Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation
6. Our objective will be to assess whether small diameter sphincterotomes and "short wire" physician controlled guidewire cannulation favors successful bile duct cannulation and minimize complications.

Detailed Summary:

1.0 BACKGROUND

Bile duct access is the most difficult part of endoscopic retrograde cholangiography (ERCP) performed for the biliary indications of bile duct stones, leak, and stricture. In the past decade there has been an evolution in the technology and approach used to achieve selective biliary cannulation, In the classic approach a standard cannula is placed into the biliary orifice and contrast injected to confirm placement. Subsequently, a long wire is passed by the assistant deeply into the duct and the cannulatome exchange for a sphincterotome which is used to perform papillotomy.

The first major change in cannulation approach has been the widespread use of the sphincterotome to obtain initial biliary access in lieu of the cannulatome. This is in part driven by economics. With the advent of endoscopic ultrasound (EUS) and magnetic resonance cholangiopancreatography (MRCP) almost all ERCP is therapeutic and sphincterotomy is typically part of this approach.1 Thus it is sensible to forgo the step of using the cannulatome which enables only diagnostic ERCP. In addition to cutting, the wire on the distal tip of the sphincterotome enables variable flexion in the direction of the bile duct, a feature lacking for the cannulatome.

Additionally, high quality comparison trials suggest that the sphincterotome is superior to the cannulatome for initial access. Schwacha et al prospectively randomized patients to bile duct cannulation with the standard cannulatome versus the sphincterotome.2 After five attempts bile duct access was achieved in 62% of those in the standard catheter group compared to 84% in the sphincterotome group. Cortus et al randomized patients to <15 attempts to access with bile duct with the cannulatome versus the sphincterotome and found that initial bili
Sponsor: University of Southern California

Current Primary Outcome: Bile Duct Cannulation [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of Cannulation Attempts [ Time Frame: 1 Year ]
  Total number of cannulation attempts to gain bile duct access.
• Post ERCP Pancreatitis [ Time Frame: 1 year ]
  Post ERCP pancreatitis defined as two of three of the following; post procedure pain >3 on the visual analogue scale, imaging imaging consistent with acute pancreatitis, and amylase >3 ULN sustained x 48 hours

Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: July 18, 2014
Date Started: April 2016
Date Completion:
Last Updated: April 13, 2016
Last Verified: April 2016