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This prospective cohort is comprised of patients with malignant biliary obstruction caused by hepatocellular carcinoma who were treated with endoscopic biliary drainage using fully covered self expandable metal stent.

After selective cannulation of the bile duct, cholangiography is obtained using contrast agent.

A guide wire is passed through the stricture, and then fully-covered metal stent is inserted under fluoroscopy guidance during ERCP.

Endoscpic biliary drainage using fully covered metal stent

Sang Hyub Lee, MD, PhD

Sang Hyub Lee, MD. PhD.

The effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.

In this study, endoscopic biliary drainage was performed using fully covered self-expancdable metal stent for malignant biliary obstruction caused by HCC. Main outcome is efficacy and safety of this procedure including clinical success rate, technical success rate, stent patency, stent dysfunction, and any adverse events during the follow-up period.

Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC

Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study

Clinical success rate is defined as a reduction of total bilirubin level above 50% or total bilirubin level less than 2 mg/dL within 1 month after the procedure. Clinical success rate of all procedures will be measured.

Technical success is defined as whether the stent is properly inserted into the stricture site and the bile or contrast agent is drained. Technical success rate of all procedures will be measured.

Stent patency duration is defined as number of days between immediately after procedure and occurrence of stent dysfunction.

Stent migration is divided in two types. Proximal dislocation is defined as the movement of the stent into the bile duct at the site of obstruction, and distal dislocation is defined as the distal displacement of the stent from the stenotic site (including cases where the stent is not observed due to self-removal). The rate of stent migration including both proximal and distal dislocation will be measured.

The stent dysfunction includes stent migration, occlusion, jaundice after stent insertion (increased more than 2-fold based on the lowest total bilirubin level), situations requiring endoscopy or radiologic intervention. The stent dysfunction rate of all patients will be measured.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC	NCT05729867	Malignant Bilia... Hepatocellular ...	Endoscpic bilia...	19 Years -	Seoul National University Hospital
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC	NCT05729867	Malignant Bilia... Hepatocellular ...	Endoscpic bilia...	19 Years -	Seoul National University Hospital

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