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Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Primary Purpose

Biliary Tract Neoplasms, Jaundice, Obstructive

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ComVi stent

Uncovered SEMS

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasms focused on measuring Stents, Endoscopy, Cholangiopancreatography, Endoscopic Retrograde

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:
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

Sites / Locations

National Cancer Center
Seoul National University Bundang Hospital
Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ComVi stent

Uncovered SEMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

The stent patency

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

Secondary Outcome Measures

Technical success

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

clinical success

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

time-to-stent occlusion

patient survival

adverse events

stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

Full Information

NCT ID

NCT01315522

First Posted

June 1, 2010

Last Updated

April 20, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01315522

Brief Title

Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

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 Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Neoplasms, Jaundice, Obstructive

Keywords

Stents, Endoscopy, Cholangiopancreatography, Endoscopic Retrograde

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ComVi stent

Arm Type

Active Comparator

Arm Description

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

Arm Title

Uncovered SEMS

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ComVi stent

Intervention Description

Endoscopic insertion of ComVi stent

Intervention Type

Device

Intervention Name(s)

Uncovered SEMS

Intervention Description

Endoscopic insertion of uncovered SEMS

Primary Outcome Measure Information:

Title

The stent patency

Description

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

Time Frame

up to 53 months

Secondary Outcome Measure Information:

Title

Technical success

Description

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

Time Frame

for the duration of ERCP procedure, an expected average of 30 minutes

Title

clinical success

Description

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

Time Frame

within 2 weeks since initial ERBD

Title

time-to-stent occlusion

Time Frame

up to 53 months

Title

patient survival

Time Frame

up to 53 months

Title

adverse events

Description

stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

Time Frame

within 4 weeks since initial ERBD

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ji Kon Ryu, MD, PhD

Organizational Affiliation

Seoul National University Hospital, Seoul National University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

27029890

Citation

Lee BS, Ryu JK, Jang DK, Chung KH, Yoon WJ, Kim J, Woo SM, Lee SH, Lee WJ, Kim YT. Reintervention for occluded metal stent in malignant bile duct obstruction: A prospective randomized trial comparing covered and uncovered metal stent. J Gastroenterol Hepatol. 2016 Nov;31(11):1901-1907. doi: 10.1111/jgh.13392.

Results Reference

derived

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Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

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