Goal: The goal of this clinical trial is to compare the effectiveness and safety of two different but highly effective treatment approaches for walled-off necrosis (WON) resulting from severe acute pancreatitis. Participant Population: The study will involve adult patients experiencing symptomatic WON due to acute necrotizing pancreatitis. Main Questions: The main questions it aims to answer are: 1. Is "endoscopy" or direct endoscopic necrosectomy (DEN) with powered endoscopic debridement (PED) as effective as "surgery" or transgastric surgical necrosectomy (SN) in achieving clinical resolution of WON within six weeks after treatment? 2. What are the rates of complications, costs, hospital length of stay, procedure time, readmission, repeat procedures and overall patient satisfaction associated with DEN with PED compared to transgastric SN? Comparison Group: Researchers will compare the outcomes of patients receiving DEN with PED to those undergoing transgastric SN to see if there are significant differences in clinical success, rates of complications, and overall healthcare costs. Participants Will: 1. Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN). 2. Undergo the assigned treatment procedure based on their group. 3. Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction. 4. Be monitored for adverse events or complications following the treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Patients will first undergo endoscopic ultrasound-guided cystgastrostomy using an electrocautery-enhanced lumen apposing metallic stent to gain access to the necrosum. Direct Endoscopic Necrosectomy will be performed using the EndoRotor® NecroMax 6.0 PED Catheter which has an outer diameter of 5.1 mm and is compatible with endoscopes that have a working channel of ≥6.0 mm.
Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric SN with the aim of creating an ample size cystgastrostomy to perform a complete debridement. In either approach, the peritoneal cavity is entered to identify the stomach through which an anterior gastrotomy is made. The retrogastric necrosum is identified either using a finder needle or ultrasound and accessed through a posterior cystgastrostomy. Transgastric SN is then manually performed, and any cyst fluid fully evacuated. The anterior gastrotomy is then closed allowing any residual necrosis or pancreatic enzyme to efflux into the stomach and enter the upper GI tract. As with endoscopy, patients with retrogastric collections are observed for a sufficient period to ensure full maturation of the necrosum.
Treatment Success at 6 weeks after Debridement
Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions. AND Radiographic resolution defined as \>70% reduction in WON on CT or MR imaging.
Time frame: From initial intervention to 6 weeks
Overall treatment success rate at end of 6-month follow-up from date of intervention
Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions after completion of 6-month follow-up. AND Radiographic resolution defined as \>70% reduction in WON on CT or MR imaging after completion of 6-month follow-up.
Time frame: From initial intervention to the end of followup at 6 months
Clinical improvement within 72 hours of debridement
Clinical improvement is defined according to the criteria used in the PANTER and TENSION trial. (8-10) "Clinical improvement" 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) will be excluded.
Time frame: From initial intervention to 72 hours after treatment
Clinical Failure at 6 months
Absence of clinical improvement or clinical deterioration
Time frame: From initial intervention to the end of followup at 6 months
30-day mortality
Mortality occurring at 30 days after intervention
Time frame: From initial intervention to followup at 30 days
Overall total cost of care
Cost of care per patient to achieve overall treatment success
Time frame: From initial intervention to the end of followup at 6 months
Overall cost of care at 6 weeks
Cost of care per patient to achieve overall primary outcome
Time frame: From initial intervention to followup at 6 weeks
Percent reduction in WON collection volume (cm3) at 6-month follow-up
Percent reduction in overall size of the WON collection volume (cm3) compared to pre-treatment CT or MR imaging.
Time frame: From initial intervention to the end of followup at 6 months
Percent resolution of solid necrosum in patients with pre-and post-MR imaging at 6-month follow up
Percent reduction in solid necrosis component of the WON collection volume (cm3) compared to pre-treatment MRI scan.
Time frame: From initial intervention to the end of followup at 6 months
Post-procedural length of hospitalization (recovery time)
Length of hospitalization from index intervention to hospital discharge
Time frame: From index intervention to hospital discharge at 6 weeks
Readmissions
Number of hospital readmissions due to disease or procedure-related symptoms or events.
Time frame: From initial intervention to the end of followup at 6 months
Reintervention rates
Need for endoscopic, radiological, or surgical intervention for additional drainage or necrotic debridement after the index intervention, excluding the follow-up procedure at 4-weeks for LAMS removal
Time frame: From initial intervention to the end of followup at 6 months
Requirement of percutaneous drain
Need for additional drainage with percutaneous drain
Time frame: From initial intervention to the end of followup at 6 months
Total anesthesia duration
Total duration of anesthesia of primary intervention
Time frame: On day of intervention (1 day)
Procedure-related adverse events
Any adverse event resulting from endoscopic intervention (yes/no)
Time frame: From initial intervention to the end of followup at 6 months
Disease-related adverse events
Any adverse event resulting from necrotizing pancreatitis
Time frame: From initial intervention to the end of followup at 6 months
Patient satisfaction
Patient satisfaction of primary intervention at 6 weeks post intervention graded on a visual analog scale (0-10)
Time frame: From initial intervention to the end of followup at 6 months
Subject quality of life (QOL)
Quality of life survey to participants at 6 month follow up. Patients will be asked to place a mark on a horizontal 10 cm line indicating his/her QoL from very poor to very good. The wording will be: "How would you rate your overall quality of life?". Higher score indicates very good quality of life and lower score indicates poor quality of life. The instrument is valid and has been used in clinical trials.
Time frame: From initial intervention to the end of followup at 6 months
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