Endoscopy 2019; 51(04): S35
DOI: 10.1055/s-0039-1681273
ESGE Days 2019 oral presentations
Friday, April 5, 2019 11:00 – 13:00: ERCP stenosis Club H
Georg Thieme Verlag KG Stuttgart · New York

A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY COMPARING SEMS PLACEMENT WITH AND WITHOUT BILIARY SPHINCTERECTOMY IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION: AN INTERIM ANALYSIS

A Anderloni
1   Humanitas Research HospitalHumanitas Clinical and Research Center, Rozzano (MI), Italy
,
A Fugazza
2   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
F D'Amico
2   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
G De Nucci
3   Endoscopy Unit, ASST-Rhodense, Garbagnate Milanese, Milan, Italy
,
G Manes
4   Endoscopy Unit, ASST-Rhodense, Rho, Milan, Italy
,
R Maselli
2   Humanitas Clinical and Research Center, Rozzano (MI), Italy
,
B Mangiavillano
5   Digestive Endoscopy Unit, Humanitas – Mater Domini Hospital, Castellanza, Varese, Italy
,
F Auriemma
5   Digestive Endoscopy Unit, Humanitas – Mater Domini Hospital, Castellanza, Varese, Italy
,
PJ Belletrutti
6   Department of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Canada
,
C Hassan
7   Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy
,
AP Maydeo
8   Baldota Institute of Digestive Sciences, Mumbai, India
,
A Repici
2   Humanitas Clinical and Research Center, Rozzano (MI), Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
18 March 2019 (online)

Also available at
 

Aims:

Aim of the study was to investigate the outcomes of patients with malignant biliary obstruction undergoing self-expandable metallic stent (SEMS) placement with and without endoscopic sphincterotomy (ES). NCT number 03628001.

Methods:

This is an interim analysis of an ongoing multicenter randomized prospective study conducted in four international tertiary referral centers from March 2016 to October 2018 in patients with malignant distal biliary obstruction with indication to SEMS placement. Patients were randomized to ES prior to fully covered (FC) SEMS placement (ES, G1) versus FCSEMS placement leaving the papilla without (No ES, G2). The primary outcomes were immediate (periprocedural) and delayed (< 30 days) post-ERCP adverse events (AE) including PEP, SEMS migration, bleeding and perforation (defined according to the ASGE lexicon).

Results:

152 patients (82 (54%) female) of mean age 69.7 (range 43 – 93 years) with distal malignant biliary obstruction were included in the study. FCSEMS were successfully deployed in all patients in both groups. 76 patients (G1) were randomized to perform ES before placement of SEMS, and 76 patients to no ES (G2). Overall, complications occurred in 24 (31.5%) patients in G1 and in 17 (22.3%) in G2 (p = 0.2008). Although not statistically significant there was a trend toward increased risk of PEP in the G2 compared to the G1 (15.8% vs. 11.8%, p = 0.4807). Fatal AEs occurred in 1 patient because of cholangitis in G1 and in 1 patient because of post ERCP pancreatitis in G2.

Conclusions:

At interim analysis, placement of biliary FCSEMS without prior ES in patients with distal common bile duct obstruction showed a lower rate of cumulative AEs. On the other hand patients in G2 reported an higher incidence of PEP (although not statiscally significant). We aim to complete enrollement to the target sample size before making final conclusions.