Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01315522

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

14.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms Jaundice, Obstructive	Device: ComVi stent Device: Uncovered SEMS	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ComVi stent ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)	Device: ComVi stent Endoscopic insertion of ComVi stent
Active Comparator: Uncovered SEMS uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)	Device: Uncovered SEMS Endoscopic insertion of uncovered SEMS

Arm

Intervention/Treatment

Active Comparator: ComVi stent

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

Device: ComVi stent

Endoscopic insertion of ComVi stent

Active Comparator: Uncovered SEMS

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

Device: Uncovered SEMS

Endoscopic insertion of uncovered SEMS

Outcome Measures

Primary Outcome Measures

The stent patency [up to 53 months]
period between stent insertion and stent occlusion or death of the patient

Secondary Outcome Measures

Technical success [for the duration of ERCP procedure, an expected average of 30 minutes]
Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression
clinical success [within 2 weeks since initial ERBD]
Clinical success was achieved in the case of ≥ 50% reduction or normalization of total bilirubin level (≤ 1.2 mg/dL)
time-to-stent occlusion [up to 53 months]
patient survival [up to 53 months]
adverse events [within 4 weeks since initial ERBD]
stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with SEMS occlusion, which was inserted either endoscopically or percutaneously, for the relief of malignant nonhilar biliary obstruction
Patients in whom the above SEMS had been inserted for no less than 7 days
Patients with one of the following:

cholangitis (as defined by fever, tenderness in the right upper quadrant or epigastrium, and/or a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion)
a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion

Patients in whom the cause of initial ERBD occlusion was identified, such as tumor overgrowth, ingrowth, and/or sludge
Age ≥ 20 years

Exclusion Criteria:

Unable to give informed consent
Patients with sepsis and/or shock not responding to medical treatment or Eastern Cooperative Oncology Group (ECOG) Performance Status 4
Patients with estimated survival < 4 weeks
Patients who had undergone curative or palliative surgical intervention
Hilar or perihilar biliary obstruction
Patients who had undergone endoscopic nasobiliary drainage,plastic stent insertion, or percutaneous transhepatic biliary drainage prior to second SEMS insertion
Covered SEMS as initial SEMS
Migration or food impaction as the cause of initial SEMS occlusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769
2	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707
3	Seoul National University Hospital	Seoul		Korea, Republic of	110-744