Clinical trial · Interventional
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
NCT03002051CI-TRIAL-00042226completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Cholecystitis | — | UNRESOLVED | — |
| Biliary Obstruction | — | UNRESOLVED | — |
| Pancreatic Necrosis | — | UNRESOLVED | — |
| Pancreatic Pseudocyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided drainage | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS guided drainage
- description
- Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent
- interventionNames
- Device: EUS-guided drainage
Primary outcomes (3)
- measure
- Clinical success for pancreatic fluid collections
- timeFrame
- 8 hrs
- description
- ① Clinical success of pancreatic fluid collections * Peudocyst: resolution more than 50% in the initial size of cyst. * Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
- measure
- Clinical success for acute cholecystitis
- timeFrame
- 8hrs
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
References
Publications (1)
- DERIVEDTeoh AYB, Kongkam P, Bapaye A, Ratanachu T, Reknimitr R, Lakthakia S, Chan SM, Gadhikar HP, Korrapati SK, Lee YN, Medarapalem J, Ridtitid W, Moon JH. Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial. Dig Endosc. 2021 Nov;33(7):1139-1145. doi: 10.1111/den.13911. Epub 2021 Jan 11. PMID 33284467