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2016-10
2018-10
2019-05
114
NCT03002051
Chinese University of Hong Kong
Chinese University of Hong Kong
INTERVENTIONAL
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
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
Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS * Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm) * Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm) * Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm) * Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm) * Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm) Outcome paramaters include technical and clinical success, adverse events.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-12-16 | N/A | 2019-12-12 |
2016-12-20 | N/A | 2019-12-13 |
2016-12-23 | N/A | 2019-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: EUS guided drainage Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent | DEVICE: EUS-guided drainage
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Clinical success for pancreatic fluid collections | 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. | 8 hrs |
| Clinical success for acute cholecystitis | - Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count. | 8hrs |
| Clinical success for obstructive jaundice | - A decrease in total bilirubin to < 50 % of the pre-stenting value within 2 weeks. | 2 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Techincal success | - Satisfactory access, placement of stent and drainage. | 1 day |
| Adverse events | * Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation. * Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs. * Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study. * Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study | 30 day |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
