Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02155244 |
| Other study ID # |
LR-1234 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 19, 2014 |
| Last updated |
June 3, 2014 |
| Start date |
January 2006 |
| Est. completion date |
May 2014 |
Study information
| Verified date |
June 2014 |
| Source |
Ospedale Regionale di Mendrisio |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Switzerland: Federal Office of Public Health |
| Study type |
Observational
|
Clinical Trial Summary
In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified
after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this
study is to determine leaving the gallbladder in situ does not reduce the morbidity rate
after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.
Description:
The prevalence of gallstone disease increases with age, and as many as one third of women
and one fifth of men over the age of 60 years have gallstones. The quoted prevalence of CBDS
in patients with symptomatic gallstones varies, but probably lies between 10 and 20%. In
Europe and Northern America 8 to 20% of cases of cholelithiasis is complicated by presence
of common bile duct stones (CBDS) during cholecystectomy. When ductal stones do become
symptomatic the consequences are often serious and can include pain, partial or complete
biliary obstruction, cholangitis, hepatic abscesses or pancreatitis. Recent guidelines for
the treatment of CBDS recommend that in patients with symptoms and clinical evaluation
suggesting ductal stones as a cause, stones should be extracted if possible, except in
selected patients that have contraindications (e.g high risks patients, refusal of
endoscopic or operative treatment).
Many different approaches are currently being used for the management of bile duct calculi.
These strategies differ considerably in terms of technical complexity, sensitivity,
specificity, effectiveness, and cost. Where initial assessment suggests a high probability
of CBDS, then it is reasonable to proceed directly to ERCP if this is considered the
treatment of choice. Intraoperative cholangiography with selective intraoperative or
postoperative ERCP is a strategy than routine preoperative ERCP, unless the presence of
common bile duct stones (CBD) is almost certain. Current data does not suggest clear
superiority of any one approach with regard success, mortality, morbidity and
cost-effectiveness. In unfit elderly people with comorbid disease leaving the gallbladder in
situ is justified after ERCP treatment. Cholangitis is more present in elderly people.
Leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for CBDS,
especially in patients with cholangitis
All 101 patients with symptomatic and suspected CBD stones admitted to Surgical Department
of "Ospedale Regionale di Mendrisio" from january 2006 to december 2013 were evaluated
retrospectively for study eligibility. Patients were followed for the duration of hospital
stay, the median hospital stay was 9 days.
From our Hospital informatic system, information on age, sex, length of hospital stay, and
procedures undertaken during hospital admissions for patients with biliary diagnoses were
retrieved. Initial patient evaluations consisted of history and physical examinations and
serum analyses for inflammatory parameters, bilirubin, alkaline phosphatase, transaminase,
and amylase. Previous history of jaundice or acute pancreatitis was recorded. In addition,
right upper quadrant abdominal sonograms and CT scan were obtained for the determination of
cholelithiasis and CBD diameter. The diagnosis of cholangitis was based on presence of
clinical evidence of infection in patients with biliary obstruction in the form of jaundice
or hyperbilirubinemia.
In our institution, patients with cholelithiasis, a CBD stones at US examination, and liver
enzyme elevation, without clinical evidence of cholecystitis or biliary pancreatitis
underwent ERCP, endoscopic sphincterotomy, and endoscopic clearance of CBD stones before
laparoscopic cholecystectomy (LC). In patients with acute cholangitis, a dilated common bile
duct on US, the first treatment was also ERCP. Patients with cholelithiasis, CBD and
intrahepatic bile duct (IHBD) dilatation, and liver enzyme elevation, in the presence of
cholecystitis, biliary pancreatitis, or apparent resolving symptomatic choledocholithiasis
underwent further evaluation with magnetic resonance imaging(MR), and these patients
underwent therapeutic ERCP when choledocholithiasis was demonstrated by MR, whereas patients
whose MR did not detect choledocholithiasis underwent LC with intraoperative cholangiography
(IOC). When we found CBD during LC, an ERCP was performed in the same operating time
("rendez-vous") or post operatively.
Endoscopic retrograde cholangiopancreatography(ERCP) with papillotomy was performed in
patients with confirmed common bile duct stones(CBDS) by a single gastroenterologist.
In our Hospital, the procedure is performed in radiological room that contains x-ray
equipment. We use a Olympus® duodenalendoscope TJF-145 for ERCP, Erbe® system for
papillotomy diathermy, and Lithotriptor® if stone crushing is necessary. The patient is in
prone position under general anesthesia. When performing endoscopic stone extraction the
endoscopist has the support of a technician or radiologist who can assist in fluoroscopic
screening and an additional endoscopy assistant/nurse to manage guide wires.
The relationship between ERCP and surgery was assessed by dividing the patients into 2
groups: patients who had ERCP without cholecystectomy (Group 1), patients who had ERCP +
cholecystectomy (Group 2). Endpoint was to detect difference in age, indication (cholangitis
and lithiasis), morbidity, effectiveness and success of CBD clearance in different groups.
