Clinical trial NCT04337333: Two-in-one Covered and Uncovered Metal Stent
Official title: Feasibility and Safety of a Newly Developed Two-in-one Covered and Uncovered Metal Stent for Inoperable Malignant Distal Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extrahepatic Bile Duct Cancer
Pancreatic Cancer
Lymph Node Metastases
Gallbladder Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Cumulative patency of inner covered stent and Two-in-one stent
timeFrame: From the date of stent insertion until the date of first documented stent dysfunction, assessed upto 12 months
Secondary outcomes:
measure: Overall patient survival
timeFrame: From the date of stent insertion until the date of death from any cause, assessed upto 12 months
measure: Stent dysfunction-free patient survival
timeFrame: 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
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeong Gi Do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
Study officials:
affiliation: Ajou University School of Medicine
name: Jin Hong Kim, MD, PhD
role: STUDY_DIRECTOR
References: