Efficacy of Video-Assisted Retroperitoneal Debridement (VARD) Over Radiological Percutaneous Interventions (RPI) in the Management of Infected Pancreatic Necrosis:An Open Labelled Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Video assisted retroperitoneal debridement compared to radiological percutaneous interventions in patients with suspected infected pancreatic necrosis.
研究概览
简要总结
Infected pancreatic necrosis is a severe complication of acute pancreatitis, requiring timely and appropriate intervention. While percutaneous catheter drainage has been widely used, it often fails to remove solid necrotic debris completely. Video-assisted retroperitoneal debridement has emerged as a minimally invasive alternative, allowing for direct debridement and better outcomes in selected patients.
Initial management of necrotizing pancreatitis is conservative, with intervention reserved for infected necrosis and clinical deterioration. Open necrosectomy, although effective, carries significant risks, including high mortality, incisional hernia, and fistula formation. Recent guidelines and trials, such as the PANTER study, have favored a step-up approach—starting with PCD and escalating to VARD if needed—due to lower morbidity and equivalent long-term outcomes.
VARD has shown efficacy, especially in deep-seated or complex collections. Studies report overall mortality around 13percent, with complications such as pancreatic fistula, bleeding, enteric fistula, and organ perforation. On average, one to three VARD procedures may be required. Approximately 61 percent of patients can be successfully treated with VARD alone.
Comparative studies, including the POINTER and TENSION trials, indicate that delayed and minimally invasive interventions are generally favorable over early or open approaches. However, VARD’s role is still evolving, and optimal patient selection remains crucial. While endoscopic techniques may offer advantages in some settings, VARD continues to play a key role in cases where PCD alone is inadequate.
This trial aims to assess the safety and efficacy of VARD compared to radiological percutaneous interventions, hypothesizing that VARD offers improved clinical outcomes in appropriate patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of more than 18 years ago with Documented infected necrotizing pancreatitis for more than 14 days of disease onset and Catheter drainage of the collection with infected necrosis is technically feasible as deemed by the Expert Radiologist and/or treating physician.
排除标准
- •Conditions with Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome),or Previous retroperitoneal intervention for necrotizing pancreatitis or Documented chronic pancreatitis.
结局指标
主要结局
To assess the efficacy of Video assisted retroperitoneal debridement compared to radiological percutaneous interventions in patients with suspected infected pancreatic necrosis.
时间窗: 1 year
次要结局
- To estimate the proportion of different outcomes among patients undergoing VARD and RPI in terms of Mortality, New onset (multi) organ failure, Bleeding requiring intervention, Perforation requiring intervention, Fistula formation,Incisional hernia, Wound infections, Endocrine and exocrine pancreas insufficiency, Number of patients with severe complications (Clavien-Dindo III or higher), Number of patients per Clavien-Dindo classification, Number of (re-)interventions, hospital and ICU length of stay, Direct costs.
研究者
DrRishit Mani
AIIMS Patna