Pancreatic Cancer Clinical Trial
Official title:
Feasibility and Safety of a Newly Developed Two-in-one Covered and Uncovered Metal Stent for 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. 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: ?Malignant biliary obstruction, 2 cm distal to the hilum ?Not eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ?Eastern Cooperative Oncology Group Performance status 0-3 Exclusion Criteria: ?Being evaluated for potential benign biliary stricture or possible operation ?History of biliary surgery except cholecystectomy ?Coagulopathy (International normalized ratio >1.5, platelet count <50,000) ?Coexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ?Inability to obtain informed consent |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ajou University Hospital | Suwon | Gyeong Gi Do |
Korea, Republic of | Ajou University Hospital | Suwon | Gyeonggido |
Lead Sponsor | Collaborator |
---|---|
Ajou University School of Medicine |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative patency of inner covered stent and Two-in-one stent | From the date of stent insertion until the date of first documented stent dysfunction, assessed upto 12 months | ||
Secondary | Overall patient survival | From the date of stent insertion until the date of death from any cause, assessed upto 12 months | ||
Secondary | Stent dysfunction-free patient survival | 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 |
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