RCT of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | November 2016 |
A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation
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.
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.
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.
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