Study Start Date: 01/01/2014
Study End Date: 01/01/2019

Prospective evaluation of a minimally invasive treatment option for extrahepatic biliary duct obstructions (EHBDO) in dogs and cats

Endoscopic retrograde cholangiopancreatography (ERCP) is an interventional endoscopic technique used for the diagnosis, and potential treatment, of biliary tract disease, pancreatitis, or pancreatic obstructive lesions in humans. To date biliary stents have been successfully placed in a small handful of normal purpose-bred dogs and clinical dogs and cats with EHBDO, and a larger clinical investigation is underway. Using an endoscope a stent is passed into the biliary tract, eliminating the need for excessive surgical manipulation. This can be left in place until the obstructive lesion resolves (ie pancreatitis), or a permanent metallic stent can be used in the case of neoplasia or stricture. This bypasses the need for re-routing biliary surgery for biliary obstruction. We are conducting a FULLY FUNDED study evaluating the use of endoscopic retrograde cholangiopancreatography with biliary stent placement or the use of a rescue subcutaneous intestinal biliary bypass device (SIBB) for the treatment of EHBDO in dogs and cats.

Study Design:
Prospective case series

Sample Size:
15 patients with EHBDO

Inclusion Criteria:

• Extrahepatic biliary obstruction from ANY cause: pancreatitis, stricture, stones, tumor
• Ability to present patients for follow-up evaluations for at least 6 months. These might be performed at a distant site, with electronic transfer of data (details will be discussed with clients).

Exclusion Criteria:

• Indication for surgical exploration (e.g. hepatic abscess)

Study Controls:
None

Study Endpoints:
Immediate and 6 month follow-up. Long-term follow-up to patient death where possible.

Samples:
Clients will be required to present their pets for follow-up evaluation at AMC or at a referral facility capable of performing the required ultrasound imaging and bloodwork. These results will be transmitted electronically for evaluation by the investigators.

External links:
Additional information can be found here: http://www.amcny.org/node/341

Costs/Reimbursements
ALL COSTS are covered for the procedure and immediate post-operative care. Follow-up after discharge are the responsibility of the owner and referring veterinarian. If EHBDO is not confirmed at the initial evaluation, or the patient is deemed unsuitable for the procedure (see exclusion criteria), the client will be responsible for costs.

Full Disclosure information:
The study is funded by a private grant from an anonymous client.
The investigator does not have a conflict of interest.
The study will be published if results are negative.
The authors will acknowledge VIN if the study is published and VIN contributed substantially to case recruitment.