A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

This will be a prospective, non blinded randomized controlled trial. We will screen and offer enrollment to all patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla and an indication for cholangiography and sphincterotomy. Informed consent will be obtained in the preoperative area after obtaining consent for the ERCP. We will randomize all patients in whom we fail to deeply cannulate the CBD using a sphincterotome (Autotome, Boston Scientific) and 0.035" guidewire (0.035" Jagwire or Dreamwire, Boston Scientific) in over 5 minutes or with more than 5 attempts and in whom the wire can be passed in a stable configuration in the Pancreatic duct (PD). We will exclude patients who have any contraindication to undergoing an ERCP, contraindications to sphincterotomy (e,g,, abnormal anatomy, uncorrectable coagulopathy) and those who have pancreas divisum. Patients will be randomized 1:1 using opaque envelopes in blocks of 4 stratified for gender. (Gender stratification is necessary as the risks of ERCP vis pancreatitis are different for males and females). In those 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 as previously described (1). In those randomized to TPS, a pancreatic sphincterotomy will be performed with the sphincterotome. The catheter will be removed with the PD wire left in place. The catheter and a second wire will be inserted and CBD cannluation attempted as for the DWT group. All patients will receive a 5Fr pancreatic stent and indomethacin 100 mg rectally to reduce the risk of pancreatitis as per our standard of care (patients with contraindications to NSAIDs (e.g., sensitivity to Indomethacin, aspirin or class, active peptic ulcer disease) will not receive Indomethacin. Patients who fail DWT (at least 10 minutes or 10 further attempts) may be crossed over to TPS at the endoscopist's discretion. Further care the patients receive will be standard of care. We will contact the patients around a months later by telephone to ask about any procedure related complications that were not reported to us. outcome measures will be assessed on day 1 at the end of the procedure and on day 30.

Who is eligible to participate?

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.

Douglas O. Faigel, M.D. 480-301-6990

Last updated:

10/3/2014

NCT ID:

NCT01792466

IRB Number:

12-007021