Introduction

Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be performed entirely transgastrically (hepatogastrostomy/EUS-HG) or transduodenally (choledochoduodenostomy/EUS-CDS). It is a feasible and effective alternative for distal malignant biliary obstruction (MBO) in failed endoscopic retrograde cholangiopancreatography. However, the preferred technique for better outcomes is less evaluated.

Aims & Methods

The aims of this study were to compare efficacy and safety of both techniques and identify predictors of adverse events.
Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EUS-BD were included. The primary outcome was the stent patency. The secondary outcomes were technical and clinical success, adverse events (AEs) of each technique, and independent risk factors for stent dysfunction.

Results

A total of 57 patients were divided into EUS-CDS (n = 30) and EUS-HGS (n = 27) groups. Among them, technical success was achieved in 89.32 % of patients (EUS-CDS 93.3 %, EUS-HG 88.2 %, P = 0.09). Clinical success was attained in 84.5 % of patients who underwent EUS-CDS group as compared to 80.1 % of patients who underwent EUS-HG (P = 0.14). The mean duration of stent patency for EUS-CDS was 230.3 days while that for EUS-HGS was 143.9 days (p = 0.01).
Adverse events occurred more commonly in the EUS-HG group (19.67 % vs. 13.3 %, P = 0.37).
In addition, the only independent risk factor for stent dysfunction was systematic treatment after EUS-BD [hazard ratio and 95% confidence interval 0.238 (0.066–0.863), p = 0.029]. Length of hospital stay was significantly shorter in the CDS group (5.6 days vs. 12.7 days, P < 0.001). The incidence of stent dysfunction of EUS-HGS was higher than EUS-CDS (35.1% versus 18.2%, 0.04), despite no significant differences even in late AEs.

Conclusion

In distal MBO, oth EUS-CDS and EUS-HG are effective and safe techniques for the treatment of distal biliary obstruction after failed ERCP. EUS-CDS may be better than EUS-HGS with longer stent patency, shorter hospital stay and fewer AEs. Furthermore, systematic treatment after EUS-BD is recommended for the improvement of stent patency.

Introduction

According to Lyon 2.0 consensus¹, a definitive diagnosis of gastro-esophageal reflux disease (GERD) requires endoscopic and/or pH-metry criteria. The recently developed and validated high-resolution manometry (HRM) metric termed the Milan Score² integrates four HRM variables related to GERD (ineffective esophageal motility (IEM), esophago-gastric junction (EGJ) contractile integral, EGJ morphology and straight leg raise (SLR) maneuver response) to quantify risk for definitive reflux. However, prediction of response to medical and surgical GERD treatment using the Milan Score has not been studied. The aim of this study is to evaluate the ability of the Milan Score to predict treatment outcome in patients with persistent GERD symptoms.

Aims & Methods

Data from patients who underwent HRM and pH-metry for persistent GERD symptoms were prospectively collected. Demographic, clinical and pathophysiological (HRM and pH-metry) data were extracted from the database, including the GERDQ questionnaire, Milan Score and acid exposure time (AET). A Milan Score ≥137 (risk rate 50%) and AET >6% were considered positive for GERD. Change in GERDQ was measured in patients with both pathologic and non-pathologic AET and Milan Score. The two methods were compared using the McNemar test to determine the non-inferiority of the Milan Score in comparison with the AET and Choen’s k coefficient was calculated to quantify the level of agreement. Receiver operating characteristics (ROC) analysis was performed using Milan Score and AET in determining improvement in GERDQ.

Results

Among 157 patients enrolled (median age 48 years, median body mass index (BMI) 24.6 Kg/m², 47% males), 67 (42.7%) had a positive Milan Score, 59 of which (88.1%) had a pathologic AET. Patients with a positive Milan Score had higher BMI and worse GERD-related metrics on HRM and pH-metry. Medical treatment was offered to 99 patients, and anti-reflux surgery to 45 subjects, therefore statistical analysis was performed in 144 patients. Overall, clinical improvement favored surgical over medical treatment (53% vs. 33%, p=0.027), and both treatments were more effective in patients with pathologic AET compared to patients with non-pathologic AET (medical: 52.9% vs. 22.2%, p=0.002; surgical: 69.6% vs. 36.4%, p=0.038). Similarly, patients with a pathologic Milan Score had better outcomes compared to patients with a non-pathologic Milan Score (medical: 61.5% vs. 13.8%, p<0.001; surgical: 76.9% vs. 21.1% surgical, p<0.001). A non-pathologic Milan Score failed to predict good treatment response in 16.7% of the patients, while a negative AET in 24.4%. The AET failed to demonstrated its superiority in predicting treatment response when compared with the Milan Score (p=0.130) and the Choen’s k coefficient was 0.62 (good agreement). ROC analysis showed an area under the curve of 0.790 for Milan Score and 0.715 for AET in predicting improvement in GERDQ.

Conclusion

The Milan Score is non-inferior to the AET in predicting response to medical and surgical GERD management. The Milan Score could therefore help identify patients who could benefit from an escalation of medical or surgical management.

References

1. Gyawali CP, Yadlapati R, Fass R et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024 Jan 5;73(2):361-371. doi: 10.1136/gutjnl-2023-330616. PMID: 37734911; PMCID: PMC10846564.
2. Siboni S, Sozzi M, Kristo I et al. The Milan score: A novel manometric tool for a more efficient diagnosis of gastro-esophageal reflux disease. United European Gastroenterol J. 2024 Mar 27. doi: 10.1002/ueg2.12565. Epub ahead of print. PMID: 38536701.