COMBINATION OF ERCP AND EUS-GUIDED BILIARY DRAINAGE (CERES) VERSUS PTBD FOR MALIGNANT HILAR BILIARY OBSTRUCTION: A MULTICENTER PROSPECTIVE COMPARATIVE COHORT STUDY (THE CERES STUDY)

Aims:

To prospectively compare efficacy of combination of ERCP and EUS-BD (CERES) including EUS-guided hepaticogastrostomy (EUS-HGS) and EUS-guided hepaticoduodenostomy (EUS-HDS) versus PTBD in malignant hilar biliary obstruction (MHBO).

Methods:

Patients with MHBO were recruited. Patients presented to endoscopy and interventional radiology service received CERES (group A) and PTBD (group B) as primary biliary drainage method, respectively. Technical and clinical success rate (TSR and CSR) and time to RBO (T-RBO = time from last successful biliary drainage to biliary reintervention procedure) were recorded. The study was conducted during March 2016 until October 2018 as a multicenter study of 3 Thai hospitals (King Chulalongkorn Memorial Hospital of Thai Red Cross Society, Tha-Bor Hospital, and Roi-Et Hospital) under the Thai Association for Gastrointestinal Endoscopy (TAGE) guidance.

Results:

45 patients (23 M, 22F) were recruited into group A (n = 23) and group B (n = 22). One patient from group A was withdrew due to loss to follow up. Overall TSR, CSR, and complication rate (CR) of group A versus B were 90.9% (20/22) vs. 100% (22/22) (p = not significant (NS)), 81.8% (18/22) vs. 86.4 (19/22) (p = NS), and 18.2 (4/22) vs. 9.1 (2/22) (p = NS), respectively. Group A had significantly longer mean T-RBO than group B (168.4 ± 135.0 vs. 51.8 ± 27.7 days, respectively; p = 0.045). At 6-month interval, median number of biliary reintervention procedures in group A was significantly lower than group B (0; IQR 0 – 1 vs. 2.5; IQR 2 – 5), respectively; p = 0.001). Death rate at 2-year interval of group A and B were 100% (16/16) and 93.8% (15/16) (p = NS), respectively.

Conclusions:

For biliary drainage in MHBO, based on results of this study, CERES provided longer patency with less frequent of RBO at 6-month interval.