Bile Duct Diseases Clinical Trial
Official title:
Safety and Efficacy of a New Baby-sphincterotome for Cannulation and Pre-cut in Failed Selective Wire-guided Bile Duct Access
Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices instruments for pre-cutting are the needle-knife and the Erlangen-type precut-sphincterotome. In 1996 a so called "baby-sphincterotome" (Easy-Cut®, MTW, Wesel, Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip was developed, which enables cannulation and pre-cutting in one step. Here the investigators report on the clinical evaluation of this device.
Interventional procedures at the bile or pancreatic duct require selective cannulation of
the desired duct and sometimes endoscopic sphincterotomy (ES). If it is not possible to
achieve selective access to the desired duct, which occurs in about 10-33 % of the cases
(1-4), the next step to ensure selective cannulation is a so-called pre-cut procedure (5-8).
For this approach a needle knife or an Erlangen-type sphincterotome are used to perform
pre-cut sphincterotomy (PCS). This pre-cut technique has been shown to be effective
especially to obtain selective bile duct access in the majority of the cases whenever
standard cannulation techniques fail. However, the reported complication rate for PCS is
substantially higher than for conventional ES (9), but may be outweighed by the clinical
benefits. A limitation of the PCS-procedure is the need to use a dedicated instrument
(either the needle knife or the Erlangen-type sphincterotome) for this indication. After
completion of the pre-cut procedure routinely the attempt access to the desired duct has to
be performed with other accessories since most pre-cut-sphincterotomes did do not allow
contrast injection or guide-wire insertion. A change of instruments before and after PCS
prolongs procedure time and increases cost. Therefore a "universal" instrument designed for
both bile duct cannulation and precutting would substantially simplify the procedure.
In 1999 the investigators described a newly developed "baby"-sphincterotome that combines
the features of a cannulating catheter and Erlangen-type precut-papillotome. In a first
series of patients this device was found to be useful for direct cannulation as well as for
precut procedures (10).
The aim of this trial was to investigate the safety and efficacy of this newly developed
baby-sphincterotome in cases of failed selective wire-guided bile duct cannulation in a
large cohort of patients.
Inclusion criteria were: evidence for bile duct obstruction with a visible stone or tumor,
dilated common bile duct > 7 mm (or > 9 mm in cholecystectomised patients) by
ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level > 1.4 mg/dl, and
serum alkaline phosphatase > 200 U/l with clinical suspicion of obstruction without evidence
for cholestatic liver disease.
Patients with severe coagulation disorders or distorted anatomy of the major papilla
(malignant infiltration of the papilla, papillary porus not identifiable, impacted stone)
and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded.
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