The Effect of Proton Pump Inhibitors on Endoscopic Treatment of Walled-off Necrosis: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total number of interventions
研究概览
简要总结
In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis (WON) based on inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either receive intravenous infusion or oral administration of continuous proton pump inhibitors (PPIs) or to undergo no PPI (nPPI) therapy after endoscopic ultrasound-guided transluminal drainage/debridement. Clinical data and patient-reported outcomes will be systematically collected at baseline and during follow-up periods. The study aims to assess whether PPI use after EUS-TD (Endoscopic Ultrasonography-Guided Transmural Drainage) increases the number of direct endoscopic necrosectomies required to managing WON. Additionally, the study will investigate the impact of PPI use on the incidence of stent occlusion and postoperative complications following EUS-TD, as well as its effect on the average duration of hospitalization and associated costs for patients with WON.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older and not exceeding 80 years of age.
- •Patients with a confirmed diagnosis of WON.
- •Patients requiring endoscopic ultrasound-guided transluminal drainage/debridement therapy.
- •Patients who have signed informed consent forms.
排除标准
- •Patients diagnosed with chronic pancreatitis who have not experienced an acute pancreatitis attack within the past three months.
- •Patients with severe coagulation disorders (International Normalized Ratio [INR] > 1.5).
- •Patients with significant thrombocytopenia (platelet count < 50 × 10^9/L).
- •Pregnant women.
- •Patients undergoing endoscopic drainage solely through the duodenum.
- •Patients with a history of gastrectomy, gastric bypass surgery, or prior surgery for pancreatic-related diseases.
- •Patients currently taking medications that may affect gastric acid secretion or metabolism, such as strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., clarithromycin, itraconazole) or inducers (e.g., rifampin, carbamazepine).
- •Patients requiring long-term use of acid-suppressing medications such as PPIs and P-CABs due to other medical conditions.
- •Patients with a history of acid-suppressive medication use (e.g., PPI) and a washout period of less than 14 days.
- •Patients with documented contraindications to PPIs or a relevant history of hypersensitivity.
研究组 & 干预措施
receive continuous proton pump inhibitor therapy following EUS-TD
干预措施: Proton Pump Inhibitors (Drug)
No PPI therapy following EUS-TD
结局指标
主要结局
Total number of interventions
时间窗: Within 6 months after EUS-TD
The total number of endoscopic interventions required to achieve successful WON treatment, including reinterventions, stents removal, and any other interventions performed during the 6-month follow-up period to manage adverse events or disease-specific events.
次要结局
- Technical Success Rate(With 24 hours after EUS-TD)
- Clinical success rate(Within 1 months after EUS-TD)
- Stent occlusion rate(Within 6 months after EUS-TD)
- Hospitalization and cost(Within 6 months after EUS-TD)
- Incidence of complications(Within 6 months after EUS-TD)