Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Biliary Tract Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315522
• Other study ID #: ERBD2SEMS
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2010
• Last updated: April 20, 2015
• Start date: June 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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:

1. 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)

2. 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Jaundice, Obstructive

Intervention

Device:
• ComVi stent
Endoscopic insertion of ComVi stent
• Uncovered SEMS
Endoscopic insertion of uncovered SEMS

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The stent patency	period between stent insertion and stent occlusion or death of the patient	up to 53 months	No
Secondary	Technical success	Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression	for the duration of ERCP procedure, an expected average of 30 minutes	No
Secondary	clinical success	Clinical success was achieved in the case of = 50% reduction or normalization of total bilirubin level (= 1.2 mg/dL)	within 2 weeks since initial ERBD	No
Secondary	time-to-stent occlusion		up to 53 months	No
Secondary	patient survival		up to 53 months	No
Secondary	adverse events	stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis	within 4 weeks since initial ERBD	Yes