EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent (NCT03002051) | Clinical Trial Compass
CompletedNot Applicable
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
China114 participantsStarted 2016-10
Plain-language summary
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB
Who can participate
Age range20 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
* Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
* The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
* Target lesion that is accessible through the transenteric approach
* The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
* The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
* The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.
Exclusion Criteria:
Patient presenting with any of the following will not be included in the study.
* Inaccessible to EUS-guided approach
* Bleeding tendency: International normalized ratio (INR) of prothrombin time \< 1.5 or platelet conunt \< 60,000/mm3
* Patients with Disseminated Intravascular Coagulation syndrome(DIC)
* Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
* Patients with other serious disease or medical condition
* Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
* Unstable heart disease despite of treatm…