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OpenTrials
Completed

NCT Number: NCT01315522

Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ComVi stent

Device

Endoscopic insertion of ComVi stent

Uncovered SEMS

Device

Endoscopic insertion of uncovered SEMS

Primary outcomes

  1. The stent patency

    Time frame: up to 53 months

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

Secondary outcomes

  1. Technical success

    Time frame: 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

  2. clinical success

    Time frame: 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)

  3. time-to-stent occlusion

    Time frame: up to 53 months

  4. patient survival

    Time frame: up to 53 months

  5. adverse events

    Time frame: within 4 weeks since initial ERBD

    stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Mar 15, 2011
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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