Safety and efficacy of unilateral versus bilateral Percutaneous Transhepatic Biliary Drainage (PTBD) in

patients with malignant obstruction of the biliary hilum: a randomized controlled study.

In patients with a malignant obstruction at the hilum of the liver, preoperative biliary drainage attempts
to improve the safety of treatment by optimizing the liver functions. In such patients there is lack of
evidence of the safety and efficacy for unilateral or bilateral PTBD. We therefore compared the two
modalities.

Methods:

Patients 18 to 70 years of age, with a good performance status (ECOG 0 to 2), surgical obstructive
jaundice due to malignant lesions involving the primary biliary confluence requiring preoperative biliary
drainage were randomized to receive unilateral or bilateral drainage. ASA Grade IV patients, those unfit
for procedure and those with a patent primary confluence on imaging were excluded. We analysed the
safety of the procedure, clinical success (decrease in bilirubin to less than 75% of pretreatment value
within a month of the procedure), technical success (successful placement of the catheter across the
block providing continuous drainage of bile), post procedure quality of life (WHO-QOLB), time taken for
bilirubin level to decrease to <5 mg/dl and fitness for surgery. The calculated sample size of this ongoing
study was 60 in each arm. An interim analysis was done.

Results:

Of the 38 patients evaluated between September 2014 and December 2015, 6 patients were excluded
(pre procedure cholangiogram showed a patent primary confluence) and 32 patients were included in
the study. 15 underwent unilateral and 17 bilateral PTBD. The patient and disease-related factors were
comparable. In the unilateral and bilateral groups, Bismuth Corlette Type II, IIIA, IIIB and IV blocks were
present in 10, 4, 1 and 0 patients and 12, 2, 2 and 1 patients, respectively. At presentation the lesion was
resectable in 9 in the unilateral and 10 in the bilateral group. Clinical success was achieved in 13 patients
(86.7%) in unilateral group and 15 patients (88.2%) in bilateral group (p=1.0). Technical success was
achieved in 13 patients (86.7%) in unilateral group and 17 patients (100 %) in bilateral group (p=0.21).
The complication rates were similar. Post-PTBD cholangitis occurred in 8 patients (53.3 %) in unilateral
group and in 8 patients (47.1%) in the bilateral group (p=1.0). Serum bilirubin levels decreased to <5
mg/dl in 7 patients (46.7 %) in the unilateral group and in 10 patients (58.8 %) in the bilateral group
(p=0.72) over a median of 25 and 21 days (p=0.19). Two patients in unilateral group and nine patients in
bilateral group were adequately optimized for definitive surgical procedure. None in the unilateral group
and six patients in the bilateral group were operated upon. QOL scores at day 0, 4 weeks and 8 weeks
were comparable. The median overall survival was 104 days (range 14 to 325 days) in the unilateral
group and 106 days (range 4 to 419 days) in bilateral group.

Conclusion:

PTBD is an effective tool for decompression of the obstructed biliary system with there being little to
choose between unilateral or bilateral drainage.