Clinical trial NCT01315522: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biliary Tract Neoplasms
Jaundice, Obstructive
Keywords: Stents
Endoscopy
Cholangiopancreatography
Endoscopic Retrograde
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: The stent patency
timeFrame: up to 53 months
Secondary outcomes:
measure: Technical success
timeFrame: for the duration of ERCP procedure, an expected average of 30 minutes
measure: clinical success
timeFrame: within 2 weeks since initial ERBD
measure: time-to-stent occlusion
timeFrame: up to 53 months
measure: patient survival
timeFrame: up to 53 months
measure: adverse events
timeFrame: within 4 weeks since initial ERBD
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul National University College of Medicine
name: Ji Kon Ryu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.