BACKGROUND AND AIM: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is performed as an alternative to the percutaneous or surgical approach. Despite high success rates, the adverse events rate is high. Recently, we used 6-mm fully covered self-expandable metal stents to prevent adverse events and allow easy re-intervention. The purposes were to evaluate the safety, feasibility, and clinical efficacy. METHODS: A prospective study to confirm the safety of EUS-HGS was carried out in six patients, followed by a trial to evaluate the feasibility and efficacy of EUS-HGS in approximately 12 additional patients. We permitted a total of 18 to 20 patients in consideration of possibility such as the deviation after providing informed consent. RESULTS: Twenty patients underwent EUS-HGS. No treatment-related adverse events described in the safety assessment criteria were seen. The technical and clinical success rates were 100% and 95%. The adverse event rate was 15%. Focal cholangitis was seen in two patients and fever in one patient. All cases were treated conservatively. Stent dysfunction was seen in 10 patients. The causes of stent dysfunction were biliary sludge (n = 6) and stent dislocation (n = 4). In nine cases, a new stent was easily inserted. Percutaneous drainage was selected in only one patient because of worsening general condition. CONCLUSIONS: The 6-mm fully covered self-expandable metal stent is safe and effective, especially for avoiding serious adverse events and allowing easy re-intervention. (UMIN000006785).
BACKGROUND AND AIM: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is performed as an alternative to the percutaneous or surgical approach. Despite high success rates, the adverse events rate is high. Recently, we used 6-mm fully covered self-expandable metal stents to prevent adverse events and allow easy re-intervention. The purposes were to evaluate the safety, feasibility, and clinical efficacy. METHODS: A prospective study to confirm the safety of EUS-HGS was carried out in six patients, followed by a trial to evaluate the feasibility and efficacy of EUS-HGS in approximately 12 additional patients. We permitted a total of 18 to 20 patients in consideration of possibility such as the deviation after providing informed consent. RESULTS: Twenty patients underwent EUS-HGS. No treatment-related adverse events described in the safety assessment criteria were seen. The technical and clinical success rates were 100% and 95%. The adverse event rate was 15%. Focal cholangitis was seen in two patients and fever in one patient. All cases were treated conservatively. Stent dysfunction was seen in 10 patients. The causes of stent dysfunction were biliary sludge (n = 6) and stent dislocation (n = 4). In nine cases, a new stent was easily inserted. Percutaneous drainage was selected in only one patient because of worsening general condition. CONCLUSIONS: The 6-mm fully covered self-expandable metal stent is safe and effective, especially for avoiding serious adverse events and allowing easy re-intervention. (UMIN000006785).