Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

NCT01315522 | Completed Phase 4

• 1 other identifier: ERBD2SEMS
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Biliary Tract Neoplasms; Jaundice, Obstructive

Keywords

Stents; Endoscopy; Cholangiopancreatography; Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

• The stent patency

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

  up to 53 months

Secondary Outcomes (5)

• Technical success

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

• clinical success

  within 2 weeks since initial ERBD

• time-to-stent occlusion

  up to 53 months

• patient survival

  up to 53 months

• adverse events

  within 4 weeks since initial ERBD

Study Arms (2)

ComVi stent

ACTIVE COMPARATOR

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

Device: ComVi stent

Uncovered SEMS

ACTIVE COMPARATOR

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

Device: Uncovered SEMS

Interventions

ComVi stent DEVICE

Endoscopic insertion of ComVi stent

ComVi stent

Uncovered SEMS DEVICE

Endoscopic insertion of uncovered SEMS

Uncovered SEMS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (3)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27029890 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms; Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ji Kon Ryu, MD, PhD

  Seoul National University Hospital, Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: March 15, 2011
• Study Start: June 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

KR (3)