RCT of the Double Wire Technique for Sphincterotomy
RCT of the Double Wire Technique for Sphincterotomy
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.
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.
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.