Study of Different Modalities of Endoscopic Ultrasound (EUS)-Guided Post-pancreatitis Pancreatic Fluid Collection Drainage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs)
研究概览
简要总结
The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice [Lin et al., 2014]. The timing of necrosectomy in WOPN drainage continues to be debated. To date, no comparative studies have been conducted to investigate the ideal timing for stent removal. Thus, the aim of our study is to:
- Assess the technical success rates, clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type, caliber and number of plastic stents and ideal timing for stent removal.
- Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates, clinical success rates, potential complications and number of sessions needed.
详细描述
Acute pancreatitis (AP) accounts for over 50% of all hospital admissions for pancreatic disease and still represents one of the most unpredictable diseases of the digestive system (NICE guideline, 2018). Therefore, AP can be linked to a number of systemic or local problems; in its most severe form, it can result in multiple organ failure and even death (Rana et al., 2015).
Pancreatic fluid collections (PFCs) are a common complication of AP, with a reported incidence of 43% (Cui et al., 2014). When there is pancreatic damage, such as AP, pancreatic trauma, postsurgery, posttransplant, or occlusion of the pancreatic duct (PD), PFCs develop. The management of PFCs must be guided by the classification of these entities according to their acuity and the presence or absence of necrosis.
Surgical drainage has been the standard of care for PFCs. The paradigm has, however, changed in favor of methods requiring endoscopic intervention and minimally invasive drainage due to recent advancements in endoscopic tools and techniques (Cui et al., 2014).
The Atlanta criteria refer to the initial global agreement on PFC classification that was created in 1993. PFCs were categorized as acute (forming within 4 weeks of pancreatitis onset) or chronic (forming after 4 weeks of pancreatitis onset) based on the original Atlanta criteria. Pancreatic necrosis, pancreatic pseudocysts (PPs), or pancreatic abscesses were the three further subtypes of chronic PFCs (Bradley et al., 1993).
Recent advances in pathophysiology and diagnostic tools warranted a revision to these criteria. The most important distinction to arise from the new classification system, known as the revised Atlanta criteria (Banks et al., 2013), is the delineation between collections containing only fluid and collections containing necrotic tissue with or without accompanying fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic sterile PFCs; symptoms include persistent abdominal pain, ileus, and gastric outlet obstruction with or without fever.
- •Proven or suspected infected PFCs with or without the presence of necrosis.
- •Patients with pancreatic pseudocyst that unresolved for at least 6 weeks after the last episode of pancreatitis and making compression on surrounding organs such as common bile duct (CBD), portal vein (PV).
排除标准
- •Patient refusal.
- •Patients with major comorbidities being unfit for general anesthesia.
- •Patients with moderate to marked ascites.
- •Patients with bleeding tendencies and impaired coagulation profile.
- •Patients with proven or suspected malignant pancreatic neoplasms.
研究组 & 干预措施
Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst
干预措施: Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst (Procedure)
结局指标
主要结局
Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs)
时间窗: 2 year
* Achievement of complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs) with clinical symptomatic improvement after 1 month and 6 months of stent placement using different EUS PFCs drainage techniques. * Compare the technical and clinical success rates and potential complications of the different techniques of EUS guided pancreatic fluid collections (PFCs) drainage.
次要结局
未报告次要终点
研究者
Abdelrahman Abodief
Assiut university Hospital
Assiut University
