39 liver-transplantated patients from different causes were recruited: 29 males and 10 females,
with a mean age of 54,6 years at the time of the procedure (min.: 41,
max.: 72 years) and a mean age of 51,4 years at the time of transplantation (min.: 24,
max.: 66 years).
The anastomosis were common bile duct-common bile duct in 34/39 cases (87%),
and were common bile duct-jejunal in the remaining 5/39 subjects (13%).
Our hospital’s institutional review board approval was used to conduct a retrospective review of the patients’ medical and imaging records.
Written consent was obtained from each patient or from their legal guardian prior to percutaneous balloon biliary dilatation,
drainage catheter interposition,
and removable fully covered self-expandable metal stent (SEMS) placement.
The procedures were performed under broad-spectrum intravenous antibiotic prophylaxis (Amoxicillin 1 g for 4 days; Gentamycin 4 mg/kg for 1 day).
Intravenous anaesthesia and sedation was given to all patients (Midazolam 0.035 mg/kg; 0.1– 0.2 mg Fentanyl).
Local anaesthesia was given subcutaneously at the puncture site (Lidocaine-HCl 1%).
During and after the procedure,
the patient’s vital signs were monitored.
An ultrasound-guided percutaneous transhepatic approach was used to enter the biliary system.
Preferably,
a left subxyphoid approach was used; if this approach failed,
a right lateral intercostal approach was used.
After percutaneous puncture with a Chiba-needle,
the bile ducts were cannulated by an introduction kit.
The stricture was then passed using a guidewire,
and a balloon catheter was positioned. A pressure up to 10 atm for 3 minutes was applied [1].
To perform bilioplasty different types and sizes balloons (diameter/lenght in mm: 6/20-40; 6/30; 7/20-30-40; 8/20-30-40; 9/20-40; 10/20-40) from different manifactures were used.
Cutting-balloons were used in case of particularly strong stenosis.
At the end of every procedure,
an inside-outside multiperforated pigtail 8 or 10 Fr drainage catheter was always placed within the biliary ducts.
Post-cholangiographic controls with contrast medium have been planned 4 weeks later in order to check the patency of biliary ducts and the presence of any restenosis.
The safety catheter,
periodically washed with NaCl 0.9% solution was removed when no changes in liver enzymes were observed and when clinical parameters were stable [2].
In the latter case,
again,
we tried to dilate the stenotic tract.
In cases in which bilioplasty were found not effective after at least 3 tries,
if the condition of the patient permitted,
a removable fully covered self expandable metal stent (diameter/lenght in mm: 8/60-80; 10/80) was placed.
In each patient,
the stent was removed under fluoroscopic guidance 3-6 months (median 4,5 months) after placement,
using a retrieval.
Although there is no consensus on the optimal duration of biliary stenting some advocate for no longer than 6 months [3,
4].
The durability of treatment was defined as freedom from restenosis of the bile ducts.
We analyzed the values of the hepatic cytolysis and cholestasis enzymes at specific time intervals.
Patients were subjected a to periodic blood sampling routine.
Biochemical data used were hepatic cytolysis indices (U/l p-ALT,
U/l p-AST,
U/l p-ALP) and cholestasis indices (µmol/l p-total bilirubin,
µmol/l p-conjugated bilirubin,
µmol/l p-γGT).
Statistical analysis was performed using SAS 9.1 software.
Continuous data were expressed as mean and standard deviation (SD) or median and interquartile range (IQR).
Continuous data were compared between two subgroups using Mann-Whitney test,
whereas pre- and post-operative variation of continuous variables was analyzed using the Wilcoxon test.
The event of failure and the timing of failure were evaluated as survival data.
Survival estimates were calculated by the Kaplan-Meier method and survival comparisons were performed using the log-rank test.
A p-value less than 0.05 was considered statistically significant.
Mean follow-up time of the study was 44,6 months (3,7 years).
Primary patency after balloon dilatation was defined as the patency achieved after the first round of balloon dilatation procedures (max.
3 consecutive dilatations in a period of max.
6 months),
confirmed by a peri-procedural cholangiography,
by the first cholangiographic check (4 weeks later) and,
in the long term,
by the significant decrease of enzymes'.
Secondary patency was defined as the group of patients who have benefited from the first cycle of expansion,
but then,
after a period of patency,
presented a restenosis; in them,
the patency has been restored after a further attempt of dilatation.
We define as “dilatation failure” as the case in which it was not possible to restore a good patency of the bile ducts even with more than three trials of expansion.
If the patient experienced dilatation failure,
no indication of stent placement has been given for his general conditions,
making surgical anastomosis' revision the unique therapeutic option.
In the group of patients in which,
after the failure of the dilatation,
it was decided to place a stent,
a division was made between those with stent patency and stent fail: the first,
at the end of follow-up,
showed complete patency of the biliary tract.
The second group was composed of patients in whom,
even after placement of the stent,
a restenosis occurred after a period of patency.