Surgical vs Endoscopic Resection Of Walled Off Pancreatic Necrosis Using The Powered Endoscopic Debridement (PED) System - The SERPENT Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 62
- 主要终点
- Treatment Success at 6 weeks after Debridement
研究概览
简要总结
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:
- 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?
- 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:
- Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN).
- Undergo the assigned treatment procedure based on their group.
- Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction.
- Be monitored for adverse events or complications following the treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Biostatistician will be blinded to the study groups while performing final study analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Direct Endoscopic Necrosectomy
Subjects randomized to the endoscopy arm will undergo direct endoscopic necrosectomy using the Powered Endoscopic Debridement System which has CE-Mark 613797 and FDA De Novo clearance in the United States (DEN200016).
干预措施: Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement (Device)
Transgastric Surgical Necrosectomy
Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric surgical necrosectomy (SN). 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.
干预措施: Transgastric Surgical Necrosectomy (Procedure)
结局指标
主要结局
Treatment Success at 6 weeks after Debridement
时间窗: 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.
次要结局
- 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 improvement within 72 hours of debridement(From initial intervention to 72 hours after treatment)
- Clinical Failure at 6 months(From initial intervention to the end of followup at 6 months)
- 30-day mortality(From initial intervention to followup at 30 days)
- Overall total cost of care(From initial intervention to the end of followup at 6 months)
- Overall cost of care at 6 weeks(From initial intervention to followup at 6 weeks)
- Percent reduction in WON collection volume (cm3) at 6-month follow-up(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(From initial intervention to the end of followup at 6 months)
- Post-procedural length of hospitalization (recovery time)(From index intervention to hospital discharge at 6 weeks)
- Readmissions(From initial intervention to the end of followup at 6 months)
- Reintervention rates(From initial intervention to the end of followup at 6 months)
- Requirement of percutaneous drain(From initial intervention to the end of followup at 6 months)
- Total anesthesia duration(On day of intervention (1 day))
- Procedure-related adverse events(From initial intervention to the end of followup at 6 months)
- Disease-related adverse events(From initial intervention to the end of followup at 6 months)
- Patient satisfaction(From initial intervention to the end of followup at 6 months)
- Subject quality of life (QOL)(From initial intervention to the end of followup at 6 months)
研究者
Abel Joseph
Principal Investigator
Stanford University