Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Biliary Tract Neoplasms

Jaundice

Cholestasis

Jaundice, Obstructive

Hyperbilirubinemia

Skin Manifestations

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)

uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)

ComVi stent

Uncovered SEMS

Ji Kon Ryu, MD, PhD

Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a limited number of reports on the management of occluded SEMS with various results. The aim of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent ERBD after the occlusion of initial SEMSs.

Endoscopic placement of self-expandable metallic stents (SEMSs) is the mainstay of palliative measures for alleviating obstructive jaundice secondary to advanced cholangiocarcinoma. Previous meta-analysis showed no significant difference in stent patency between covered and uncovered SEMS, which are currently available. However, information on secondary SEMS insertion is still scarce, and there has been no prospective trial comparing efficacy of secondary stenting between covered and uncovered SEMS for the management of occluded metal stent in malignant biliary obstruction. Previously, only two small retrospective studies addressed this issue. Given the absence of prospective trial on re-intervention for occluded SEMS in malignant biliary obstruction, we aimed to prospectively compare the efficacies and complication rates of secondary ComVi stent (cSEMS) and uSEMS for the management of such condition.

Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Re-intervention for Occluded Biliary Metal Stent in Malignant Distal Bile Duct Obstruction: a Prospective Randomized Multi-center Trial Comparing Covered and Uncovered Metal Stent

period between stent insertion and stent occlusion or death of the patient

Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression

Clinical success was achieved in the case of ≥ 50% reduction or normalization of total bilirubin level (≤ 1.2 mg/dL)

stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	NCT01315522	Biliary Tract N... Jaundice, Obstr...	ComVi stent Uncovered SEMS	20 Years -	Seoul National University Hospital
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	NCT01315522	Biliary Tract N... Jaundice, Obstr...	ComVi stent Uncovered SEMS	20 Years -	Seoul National University Hospital
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	NCT01315522	Biliary Tract N... Jaundice, Obstr...	ComVi stent Uncovered SEMS	20 Years -	Seoul National University Hospital

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