Cholangiopancreatography, Endoscopic Retrograde Clinical Trial
Official title:
A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation
Verified date | July 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of attempts needed to achieve deep cannulation with a second wire. | Number of attempts needed to achieve deep cannulation with a second wire. | Day one | |
Secondary | Time from randomization to deep cannulation. | Time from wire stable in the pancreatic duct until the second wire enters the bile duct | day of the procedure |
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