RCT of the Double Wire Technique with or without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 12-007021
  • NCT ID:

    NCT01792466
  • Sponsor Protocol Number:

    12-007021

About this study

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 attempts 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 can increase 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria

  1. All patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla.
  2. Failure to deeply cannulate the CBD in over 5 minutes and with more than 5 attempts.
  3. Stable wire placement into the Pancreatic duct (PD).

Exclusion criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Douglas Faigel, M.D.

Contact us for the latest status

Narcelle Jean-Louis

(480)301-4714

JeanLouis.Narcelle@mayo.edu