Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System
- Conditions
- Pancreatic NecrosisPancreatitis
- Registration Number
- NCT06691919
- Lead Sponsor
- Stanford University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- Patients 18 years of age or greater.
- Patients with first episode of symptomatic WON+ due to acute pancreatitis (+Persistent fatigue, malaise, abdominal pain, gastric outlet obstruction, early satiety, fever, chills, jaundice, reduced appetite, persistent nausea/vomiting, steatorrhea)
- Patients who are candidates for surgical or endoscopic necrosectomy of WON as deemed by a multidisciplinary committee of HPB surgeons and therapeutic endoscopists.
- Patients who can tolerate repeat procedures.
- 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.
- Documented untreated pseudoaneurysm within WON.
- Subject unable or unwilling to provide informed consent.
- Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using pre-procedural imaging).
- Coagulation disorders or anti-coagulant therapy which cannot be discontinued for the intervention to an absolute cardiac or vascular indication such as ACS, Stroke, Mechanical cardiovascular valves.
- 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.
- Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
- Non-communicating pancreatic or extra-pancreatic fluid collections.
- Extensive abdominal surgical history due to peritoneal adhesions, prior open or recent operation during pancreatitis course, or remote gastric surgery that precludes a transgastric surgical cystgastrostomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment Success at 6 weeks after Debridement From initial intervention to 6 weeks 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.
- Secondary Outcome Measures
Name Time Method Overall treatment success rate at end of 6-month follow-up from date of intervention From initial intervention to the end of followup at 6 months 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.Clinical improvement within 72 hours of debridement From initial intervention to 72 hours after treatment 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.Clinical Failure at 6 months From initial intervention to the end of followup at 6 months Absence of clinical improvement or clinical deterioration
30-day mortality From initial intervention to followup at 30 days Mortality occurring at 30 days after intervention
Overall total cost of care From initial intervention to the end of followup at 6 months Cost of care per patient to achieve overall treatment success
Overall cost of care at 6 weeks From initial intervention to followup at 6 weeks Cost of care per patient to achieve overall primary outcome
Percent reduction in WON collection volume (cm3) at 6-month follow-up From initial intervention to the end of followup at 6 months Percent reduction in overall size of the WON collection volume (cm3) compared to pre-treatment CT or MR imaging.
Percent resolution of solid necrosum in patients with pre-and post-MR imaging at 6-month follow up From initial intervention to the end of followup at 6 months Percent reduction in solid necrosis component of the WON collection volume (cm3) compared to pre-treatment MRI scan.
Post-procedural length of hospitalization (recovery time) From index intervention to hospital discharge at 6 weeks Length of hospitalization from index intervention to hospital discharge
Readmissions From initial intervention to the end of followup at 6 months Number of hospital readmissions due to disease or procedure-related symptoms or events.
Reintervention rates From initial intervention to the end of followup at 6 months 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
Requirement of percutaneous drain From initial intervention to the end of followup at 6 months Need for additional drainage with percutaneous drain
Total anesthesia duration On day of intervention (1 day) Total duration of anesthesia of primary intervention
Procedure-related adverse events From initial intervention to the end of followup at 6 months Any adverse event resulting from endoscopic intervention (yes/no)
Disease-related adverse events From initial intervention to the end of followup at 6 months Any adverse event resulting from necrotizing pancreatitis
Patient satisfaction From initial intervention to the end of followup at 6 months Patient satisfaction of primary intervention at 6 weeks post intervention graded on a visual analog scale (0-10)
Subject quality of life (QOL) From initial intervention to the end of followup at 6 months 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.