An interventional study of Two-in-one stent in Extrahepatic Bile Duct Cancer, Pancreatic Cancer and Lymph Node Metastases, sponsored by Ajou University School of Medicine. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Treatment
Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency. To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced. In the current study, the investigators aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.
Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. As the survival time for those patients has improved due mainly in part to development of chemotherapeutic intervention, it is becoming important to prevent recurrent cholangitis and liver failure by prolonging the SEMS patency, leading to continuation of chemotherapy and better prognosis. Therefore, one-time stent insertion before disease-progression-related death is an ultimate goal of developing an ideal biliary stent.
SEMSs have been found to be superior to plastic stents in terms of the stent patency, because it prevent accumulation of biliary sludge owing to larger diameter. The ideal designs of biliary SEMSs for prolongation of the stent patency include 1) bare metal mesh for tissue embedding to prevent stent migration, 2) covering material to counteract neoplastic tumor ingrowth, and 3) anti-reflux structure to reduce enteric biliary reflux. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency.
To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced in the field of the interventional radiology, but further data accumulation is needed to assess the comparability with various conventional SEMS types in terms of stent patency, reintervention efficacy, and clinical outcomes following reintervention, because in this system two metal stents are implanted at once exclusively via percutaneous route and clogged inner covered stent cannot be removed at the time of the reintervention. Recently a new covered and uncovered SEMS in which the clogged inner stent can be endoscopically removed leaving the outer stent in place, was introduced. In the current study, we aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.
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This study's planned enrollment of 100 is above the median of 90 across 127 interventional studies indexed under Lymphatic Metastasis.
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ㆍMalignant biliary obstruction, 2 cm distal to the hilum ㆍNot eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ㆍEastern Cooperative Oncology Group Performance status 0-3
Exclusion Criteria:
ㆍBeing evaluated for potential benign biliary stricture or possible operation ㆍHistory of biliary surgery except cholecystectomy ㆍCoagulopathy (International normalized ratio >1.5, platelet count \<50,000) ㆍCoexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ㆍInability to obtain informed consent
Endoscopic placement of a Two-in-one stent into the extrahepatic bile duct, considering the longitudinal location of the stricture segment and predicted safety margin
Device: Two-in-one stent
Endoscopic placement of a Two-in-one metal stent into extrahepatic bile duct
Cumulative patency of inner covered stent and Two-in-one stent
Time frame: From the date of stent insertion until the date of first documented stent dysfunction, assessed upto 12 months
Overall patient survival
Time frame: From the date of stent insertion until the date of death from any cause, assessed upto 12 months
Stent dysfunction-free patient survival
Time frame: From the date of stent insertion until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months
Plan to share: No
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Ajou University School of Medicine