Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation

NCT02197338 | Completed DMC

• 1 other identifier: Biliary Cannulation Trial
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages.
4. 4.At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care.
5. 5.Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation
6. 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.

Conditions

Cholestasis, Extrahepatic

Keywords

cholangiopancreatography, endoscopic retrograde

Outcome Measures

Primary Outcomes (1)

• Bile Duct Cannulation

  The primary outcome is successful initial cannulation as defined by bile duct with the assigned technology (ie size of cannulatome and type of wire system) within the first 8 attempts. The rates of cannulation among the 4 groups will be compared.

  1 year

Secondary Outcomes (2)

• Number of Cannulation Attempts

  1 Year

• Post ERCP Pancreatitis

  1 year

Other Outcomes (10)

• Number of times wire is passed into PD

  1 year

• Number of times PD is opacified with contrast

  1 year

• Fluoroscopy time (seconds).

  1 year

Study Arms (4)

Short Wire, Small Tome

EXPERIMENTAL

Short wire system, small sized sphincterotome will be used to perform the Intervention of Bile Duct Cannulation.

Other: Bile Duct Cannulation

Short Wire, Standard Tome

ACTIVE COMPARATOR

Short wire system, standard sized sphincterotome will be used to perform the Intervention of Bile Duct Cannulation.

Other: Bile Duct Cannulation

Long Wire, Small Tome

ACTIVE COMPARATOR

Long wire system, small sized sphincterotome will be used to perform the Intervention of Bile Duct Cannulation.

Other: Bile Duct Cannulation

Long Wire, Standard Tome

ACTIVE COMPARATOR

Long wire system, standard sized sphincterotome will be used to perform the Intervention of Bile Duct Cannulation.

Other: Bile Duct Cannulation

Interventions

Bile Duct Cannulation OTHER

Initial bile duct cannulation (first 8 attempts) will be made in each subject using one of the four cannulation strategies described in the 4 arms. The arm for each subject will be assigned by randomziation.

Long Wire, Small Tome; Long Wire, Standard Tome; Short Wire, Small Tome; Short Wire, Standard Tome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing ERCP at LAC+USC Medical Centers for standard indications including bile duct stones, bile leak, and biliary obstruction will be included.

You may not qualify if:

• Prior ERCP with sphincterotomy
• Prior ERCP with failed bile duct cannulation
• Pregnant, imprisoned, under age 18, unable to give informed consent
• Prior biliary diversion surgery will be excluded
• Those who require ERCP only for pancreatic duct indications will also be excluded as bile duct cannulation is not clinically necessary in this group

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (4)

• Kawakami H, Maguchi H, Mukai T, Hayashi T, Sasaki T, Isayama H, Nakai Y, Yasuda I, Irisawa A, Niido T, Okabe Y, Ryozawa S, Itoi T, Hanada K, Kikuyama M, Arisaka Y, Kikuchi S; Japan Bile Duct Cannulation Study Group. A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study. Gastrointest Endosc. 2012 Feb;75(2):362-72, 372.e1. doi: 10.1016/j.gie.2011.10.012.

  PMID: 22248605 RESULT

• Draganov PV, Kowalczyk L, Fazel A, Moezardalan K, Pan JJ, Forsmark CE. Prospective randomized blinded comparison of a short-wire endoscopic retrograde cholangiopancreatography system with traditional long-wire devices. Dig Dis Sci. 2010 Feb;55(2):510-5. doi: 10.1007/s10620-009-1052-5.

  PMID: 19957034 RESULT

• Abraham NS, Williams SP, Thompson K, Love JR, MacIntosh DG. 5F sphincterotomes and 4F sphincterotomes are equivalent for the selective cannulation of the common bile duct. Gastrointest Endosc. 2006 Apr;63(4):615-21. doi: 10.1016/j.gie.2005.10.041.

  PMID: 16564862 RESULT

• Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. doi: 10.1016/s0016-5107(04)02463-0. No abstract available.

  PMID: 15672074 RESULT

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• James Buxbaum, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

US (1)