Encapsulated pancreatic necrosis Walled-off pancreatic necrosis pancreas necrosis
Conditions
Interventions
2 days following the placement of EUS Guided Drainage and determination, if the
study subject meets the I/E criteria, a direct endoscopic necrosectomy
procedure can occur. Subjects will be randomize
however, if the procedure cannot be completed using the 5.0
mm catheter the 3.2 mm EndoRotor Catheter may be used. The reason for using
the 3.2 mm catheter will be recorded on the applicable CRF.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients 18 years of age or greater. 2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage. a. Stent must be in place for a minimum of 2 days prior to the DEN procedure. 3. Patients who can tolerate repeat endoscopic procedures. 4. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments. 5. ASA classification
Exclusion criteria
Exclusion criteria: 1. Documented pseudoaneurysm > 1 cm within the WON. 2. Subject unable or unwilling to provide informed consent. 3. Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using endoscopy or endoscopic ultrasound). 4. Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed). 5. Any condition that in the opinion of the Investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure. 6. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. 7. Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial. 8. Prior necrosectomy on existing collection. 9. Greater than 2 pancreatic / extra-pancreatic fluid collections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Mean total necrosectomy time to achieve resolution of WON. Necrosectomy time is measured in minutes from the start of the debridement procedure to completion of the debridement procedure, including time to swap devices, and comprises the summation of the individual necrosectomy times in case of multiple procedures. a. Resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions. d. Clinical improvement is defined according to the criteria used in the PANTER trial and TENSION trial.8,15 *Clinical improvement* was defined as: i. Improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) according to the Investigator*s medical judgement within 72 hours of the procedure, or; ii. At least 10% improvement of two out of three parameters of infection (i.e. C-reactive protein, leucocyte count or temperature) within 72 hours of the procedure. Deterioration of these parameters by other infectious causes (e.g. urinary tract infection) were excluded. Clinical failure was defined as the absence of clinical improvement or clinical deterioration. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be summarized using descriptive statistics. Any testing done to compare EndoRotor to conventional DEN will be considered hypothesis generating in nature. 1. The occurrence of all adverse events measured from the Index Procedure through the 6 Month Post Necrosectomy Follow-up Visit. 2. Conversion of DEN to surgery. 3. Length of hospitalization measured in days from the Index Procedure, including days in intensive care unit (ICU) vs. standard in-patient hospitalization. 4. Mean total cost of care per subject including: procedure costs, debridement devices used during the procedure, and inpatient hospital stay from the date of procedure to the date of discharge based on reimbursement fee structure expressed in US dollars, Euros or UK Pounds respectively. a. Procedure costs will be based on the cost of an endoscopic retrograde cholangiopancreatography (ERCP) which covers room, X-ray, sedation, personnel, and other materials. 5. Percent reduction in WON collection volume (cm3) as assessed by contrast enhanced computed tomography (CECT) scan or magnetic resonance imaging (MRI) (Baseline vs. completion of necrosectomy). a. Endoscopic ultrasound (EUS) may be used for imaging only when a subject is contraindicated for MRI and CECT. b. WON collection volume will be measured as follows: i. Length = longest diameter in cm/mm in the axial plane (left - right) ii. Width = the longest diameter in cm/mm (frontal - dorsal) in the same axial plane as the length, perpendicular on the longitudinal axis. iii. Height = longest diameter in cm/mm on coronal plane (cranial - caudal) 6. Procedure time measured in minutes from the point of per-oral scope insertion to scope removal (scope-in / scope-out). 7.Total number of procedures required to achieve resolution of WON. Resolution is defined using the definition in the primary endpoint. 8. Subject quality of life (QOL) as assessed by a SF-36 questionnaire performed at Base | — |
Countries
Czech Republic, Denmark, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactI.J Visser
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed