Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial

Abstract

(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study. (2) Methods: Patients with unresectable malignant hilar biliary obstruction were assigned to unilateral or bilateral group. At first, patients underwent endoscopic nasobiliary drainage (ENBD), and subsequently underwent self-expandable metallic stent (SEMS) deployment. Primary outcomes were the functional success rate of ENBD and time to recurrent biliary obstruction (TRBO) after SEMS deployment. (3) Results: During the study period, 38 and 39 patients were enrolled in the unilateral and bilateral groups. The functional success rate was similar in the uni- and bi-ENBD group (57% vs. 56%; p = 0.99), but the rate of additional drainage was higher in uni-ENBD group. Although TRBO and overall survival time after SEMS deployment were not different between the groups (p = 0.11 and 0.78, respectively), the incidence of early adverse events tended to be higher in the bi-SEMS group (5.3% vs. 28%; p = 0.11). (4) Conclusions: Our study failed to demonstrate the superiority of bilateral over unilateral biliary drainage in terms of functional success rate and TRBO.

Keywords: cholestasis; endoscopic retrograde cholangiopancreatography; endoscopy; jaundice; stents.

Figure 1

Fluoroscopic images of endoscopic biliary drainage for hilar biliary obstruction. (A) Cholangiogram in a patient with hilar cholangiocarcinoma. (B) uncovered self-expandable metallic stents were deployed in a stent-in-stent fashion.

Figure 2

Flowchart of selection into uni- and bi-lateral endoscopic nasobiliary drainage group for patients with unresectable malignant hilar biliary obstruction. Bi-ENBD, bilateral endoscopic nasobiliary drainage; Bi-SEMS, bilateral self-expandable metallic stent; ENBD, endoscopic nasobiliary drainage; SEMS, self-expandable metallic stent; Uni-ENBD, unilateral endoscopic nasobiliary drainage; Uni-SEMS, unilateral self-expandable metallic stent.

Figure 3

Bilirubin decrease rates after unilateral (A) and bilateral (B) endoscopic nasobiliary drainage. The serum total bilirubin level was log-transformed, and bilirubin decrease rate was estimated using the nonlinear least-squares method (Step 1).

Figure 4

Kaplan–Meier curve of recurrent biliary obstruction (A) and overall survival (B) in the uni- and bi-SEMS group. p values were calculated using the log-rank test (Step 2). Bi-SEMS, bilateral self-expandable metallic stent; CI, confidence interval; NA, not available; OS, overall survival; SEMS, self-expandable metallic stent; TRBO, time to recurrent biliary obstruction; Uni-SEMS, unilateral self-expandable metallic stent.