Chyle Leak After Pancreatic Surgery - CLAP
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Postoperative morbidity
研究概览
简要总结
Currently it is unclear whether postoperative chyle leak (CL) after pancreatic surgery requires treatment. Thus, the present study aims to compare dietary treatment of CL with drain removal despite of persistent CL.
详细描述
With an incidence of up to 11%, postoperative chyle leak (CL) is a frequent phenomenon after pancreatic surgery, where extensive lymph node dissections are indispensable. Postoperative CL is frequently treated with either medium-chain triglyceride diet (MCT-diet) or total parenteral nutrition (TPN). Ignoring CL and removing the surgical drains irrespective of CL may also be discussed. While dietary restrictions are known to hinder postoperative convalescence and prolong the length of stay at the hospital, recent retrospective data show that leaving CL untreated is not associated with an increased morbidity rate. More precisely, removing the surgical drains irrespective of CL does not result in an increased incidence of CT-guided drainages. However, prospective data on CL after pancreatic surgery do not exist in the literature. Accordingly, the present trial aims to compare treatment of CL with dietary restrictions to removing the surgical drains irrespective of CL.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Pancreatic surgery of any kind
排除标准
- •Liver cirrhosis > Child-Pugh grade A
- •History of portal vein thrombosis
- •Portal Hypertension
- •Dropout Criteria:
- •Irresectable Tumor (no surgical resection)
- •Biochemical leak or postoperative pancreatic fistula (POPF)5
- •Serous drainage on POD 5
- •Peritoneal carcinomatosis
- •Portal vein thrombosis
- •Postoperative bile leak
- •Drain volume >1000ml on POD5
研究组 & 干预措施
Ignoring CL (group A)
Standard care irrespective of CL.
干预措施: Standard care irrespective of CL (Other)
Dietary treatment (group B)
Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL.
干预措施: Dietary treatment (MCT-diet) (Other)
结局指标
主要结局
Postoperative morbidity
时间窗: 30 days postoperatively
Complications ≥ Clavien-Dindo3 grade IIIa
次要结局
- Length of stay at the hospital(90 days postoperatively)
- Time until drain removal(30 days postoperatively)
- Readmission to the hospital(90 days postoperatively)
- Weight change(The day before surgery until postoperative day 10)
- Body mass index (BMI) change(The day before surgery until postoperative day 10)
- International normalized ration (INR) change(The day before surgery until postoperative day 10)
- Albumin change(The day before surgery until postoperative day 10)
- Postoperative cortisol level(8 days postoperatively)
- Freiburg index of patient satisfaction(Postoperative day 10)
研究者
Jan D'Haese
Associate professor, principal investigator
Ludwig-Maximilians - University of Munich