Introduction: Primary sclerosing cholangitis (PSC) is a chronic cholestatic disorder characterized by multi-focal bile duct strictures. The presence of a dominant stricture in PSC is considered to be a poor prognostic factor. The optimal endoscopic strategy (stent versus balloon dilation) is unclear due to paucity of available data and small number of patients in existing studies.
Methods: We used a large national database (TriNetX, LLC.), which aggregates data from 59 healthcare organizations comprising over 70 million patients using ICD-10 and CPT codes to construct a case-control study. All patients were adults ≥ 18 years with PSC with a dominant stricture. Cases underwent endoscopic stent placement, whereas controls underwent endoscopic balloon dilation. We propensity matched the groups for age, male sex, white race, BMI ≥ 30, diabetes, ulcerative colitis, smoking, alcohol use, history of appendectomy and hypertriglyceridemia. Cases and controls were compared for 30-day risk of procedure related cholangitis, perforation, bleeding and 30-day hospital readmission rates. We also compared 14-day risk of post-ERCP pancreatitis, and risk of 1-year and 3-year mortality between cases and controls.
Results: In the matched cohort analysis, patients who received a stent had a higher 30-day risk of procedure related cholangitis when compared to those who only underwent balloon dilation (7.7% vs. 2.8%, OR = 2.8, 95% CI = 1.2, 6.9). There were no significant differences between the two groups with respect to 30-day hospital readmission rates (26% vs. 22%, OR = 1.2, 95% CI = 0.9, 1.8). Similarly, there were no differences between the stent and the balloon dilation groups in terms of 14-day post procedural pancreatitis (6.8% vs. 4.5%, OR = 1.5, 95% CI = 0.7, 3.1). Patients in the stent group had a higher risk of 1-year mortality (8% vs. 3%, OR = 2.8, 95% CI = 1.3, 5.9) and 3-year mortality (13% vs. 6%, OR = 2.3, 95% CI = 1.3, 4.0) as compared to balloon dilation (Table 1). Outcome data on post-procedural bleeding, perforation and 30-day mortality were too small to be able to detect differences between cases and controls.
Discussion: Patients with PSC related dominant stricture who had stent placement seem to have a higher risk of immediate (within 30 days) procedure related acute cholangitis, as well as higher 1-year and 3-year mortality. Larger prospective randomized clinical trials are necessary to further clarify the differences in outcomes between these two procedures.
