Background and Study Aims: Increasing numbers
of patients are undergoing endoscopic retrograde cholangiopancreatography
(ERCP) prior to laparoscopic cholecystectomy, and more departments and doctors
are performing ERCP, while new data from large prospective series have documented
the risks of both diagnostic and therapeutic ERCP. The establishment in Denmark
of a Patient Insurance Association, which has covered injury caused during
investigation and treatment in public hospitals since July 1992, has made
it possible to collect and analyze a large prospective series of ERCP complications
for which compensation has been claimed.
Patients and Methods: Thirty-nine consecutive
claims for compensation due to complications after ERCP occurring between
1 July 1992 and 31 December 1996 were investigated. Case notes were reviewed,
along with laboratory reports and radiographs. The complications were classified
according to the international consensus.
Results: Claims for compensation were made
in 39 cases from 25 hospitals. The indication for ERCP was appropriate in
31. Precut papillotomy for access had been performed in seven. The severity
of the complications was mild in one patient, moderate in three patients,
severe in 24, and fatal in nine; in two cases, the severity was not classifiable.
The complications were: pancreatitis in 23 patients (seven cases fatal, one
of which had involved a precut procedure), bleeding in two, perforation in
nine (six had a precut procedure, one died), and other reasons in five (including
one fatal case). Among the nine fatal cases, cannulation had not been achieved
in two and the endoscopic retrograde cholangiogram was normal in four, one
of whom underwent a sphincterotomy. One patient with a previous adenoma had
an endoprosthesis removed, developed gangrenous cholecystitis afterward, and
died. Thirty patients were eligible for compensation. The rejected cases included
mild and moderate pancreatitis, a case of fatal hemorrhagic pancreatitis in
which the patient had refused blood transfusion, and one patient who had pancreatitis
prior to ERCP.
Conclusions: ERCP, even for diagnostic purposes,
may be associated with very serious and even fatal complications. The use
of the precut procedure for access should still be considered dangerous. Other
means of investigating the bile ducts should be developed. If endoscopic ultrasonography
and magnetic resonance cholangiography prove to have the same diagnostic value
as ERCP, which must be considered the gold standard for visualizing the ducts
today, they might replace ERCP as the primary investigation in patients with
an intermediate or low risk of bile duct stones; this would reduce the numbers
of patients exposed to the risks of ERCP
