The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Length of hospital stay after debridement
研究概览
简要总结
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.
详细描述
This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years.
- •Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
- •Patients undergoing open debridement for infected pancreatic necrosis
排除标准
- •Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).
- •Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.
- •Patients with pre-existing hematological diseases prior to AP.
- •Patients undergoing laparoscopic or nephroscopic debridement.
结局指标
主要结局
Length of hospital stay after debridement
时间窗: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
The total length of hospital stay after debridement, including readmissions.
Degree of pancreatic sinistral portal hypertension
时间窗: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
The degree of pancreatic sinistral portal hypertension after intervention
次要结局
- Time of all draining tubes removal(From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years))
- Abdominal lavage(Perioperative)
- Intensive Care Unit stay post Operation(Perioperative)
- Pancreatic Fistula(Perioperative)
- Number of Draining Tube when Discharged(Perioperative)
- Time of all draining tubes removal(From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years))
- Cost post debridement in the first hospitalization(Perioperative)
- Number of unplanned re-admissions(From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years))
- Number of unplanned operations(From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years))
- Number of percutaneous drainage after debridement(From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years))
- Antibiotic use after treatment(Perioperative)
- Abdominal lavage(Perioperative)
- Life quality one year after treatment(Within one year after the last subject was treated)
研究者
TingBo Liang
Director physician
Zhejiang University