RCT of the Double Wire Technique for Sphincterotomy

NCT01792466 | Terminated

• 1 other identifier: 12-007021
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening. Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Sphincterotomy, Endoscopic; VATER'S AMPULLA

Keywords

difficult biliary cannulation

Outcome Measures

Primary Outcomes (1)

• Number of attempts needed to achieve deep cannulation with a second wire.

  Number of attempts needed to achieve deep cannulation with a second wire.

  Day one

Secondary Outcomes (1)

• Time from randomization to deep cannulation.

  day of the procedure

Study Arms (2)

Transpacnreatic sphincterotomy

EXPERIMENTAL

In patients randomized to TPS, a transpancreatic sphincterotomy will be performed with the sphincterotome superficially in the pancreatic duct over a wire.

Procedure: Transpancreatic sphincterotomy

Double wire without sphincterotomy

NO INTERVENTION

In patients randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation

Interventions

Transpancreatic sphincterotomy PROCEDURE

A sphinctertome will be placed into the pancreatic duct over a guidewire and the sphincter will be cut in the direction of the bile duct

Transpacnreatic sphincterotomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla
• Failure to deeply cannulate the CBD in over 5 minutes and with more than 5 attempts

You may not qualify if:

• \. Any contraindication to undergoing an ERCP. 2. Contraindications to sphincterotomy. 3. Pancreas divisum.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Study Officials

• Douglas Faigel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)