Endoscopic biliary sphincterotomy in malignant biliary obstruction: is it indicated in case of stent placement? A meta-analysis.

Introduction: Endoscopic biliary stenting is the treatment of choice in presence of malignant biliary obstruction (MBO), especially if palliative treatment. The role of endoscopic biliary sphincterotomy (EBS) before stent insertion is not clearly defined. The primary outcome of our meta-analysis was to assess the technical success of biliary (plastic or metal) stent insertion. Secondary outcomes included early complications within 30 days from ERCP and late complications which (from 30 days since ERCP). Materials and methods: We performed a literature search by using PubMed, SCOPUS, Google Scholar and the Cochrane Central Register of Clinical Trials (up to February 2017) to identify full-text studies evaluating the efficacy and safety of stent positioning, with and without EBS, in patients with MBO not suitable to surgery. Results: 14 papers were assessed via full text for eligibility. 8 articles were excluded leaving 6 prospective studies (total of 711 patients). Technical success: The overall rate of biliary stent insertion was not significantly different: 384/392 patients (98%) in the no-EBS group versus 331/339 (97.6%) in the EBS arm (OR: 1.05; 95%CI, 0.42-2.63). Early complications: The overall early AEs developed in 43/392 (11%) of patients whithout EBS versus 68/339 (20.1%) of patients who received EBS, with a significantly difference (OR: 0.55; 95%CI: 0.33-0.92). Post-ERCP pancreatitis (PEP) was no significantly different in the two groups: 24/392 (6.1%) in no-EBS group versus 17/339 (5%) in EBS group (OR: 1.33; 95%CI: 0.68-2.59). The bleeding was significantly different in patients without EBS: 0/351 of patients in no-EBS group versus 15/298 (5%) in the EBS group (OR: 0.12; 95% CI, 0.03-0.45). The rate of duodenal perforation was not significantly different: 1/320 (0.3%) in no-EBS versus 4/260 (1.5%) in EBS (OR: 0.52; 95%CI: 0.09-2.88). Early cholangitis was significantly lower in patients who didn’t receive EBS: 13/392 (3.3%) patients in no-EBS group vs 25/339 (7.4%) subjects in the EBS group (OR: 0.38; 95%CI: 0.17-0.83). Early mortality rate was 0% in both groups. Late complications: No significantly difference occurred in the overall late adverse events in the two groups: 50/251 patients (19.9%) in no-EBS group vs 38/201 subjects (18.9%) in the EBS group (OR: 0.93; 95%CI: 0.56-1.53). No significantly differences in stent occlusion (11.6% patients in no-EBS vs 11.4%in EBS - OR: 0.90; 95%CI: 0.4-2.0). No significantly differences in stent migration (4% in no-EBS group vs 5.5% - OR: 0.81; 95%CI: 0.29-2.25). No significantly differences in late cholangitis (2.6% in no EBS vs 0% in EBS group - OR: 1.83; 95%CI: 0.17-19.85). Long-term mortality was not significantly different (2.5% in no-EBS group and 2.9% in the EBS arm - OR: 1.18; 95%CI: 0.22-6.29). Conclusions: Our meta-analysis showed no significantly differences in technical success and in PEP. In consideration of the significantly increase of the overall AEs in the EBS group, and in particularly of the bleeding and cholangitis, the EBS seems not be recommended in patients not suitable to surgery undergone biliary stenting.