Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Postoperative pancreatic fistula (grade B+C)
研究概览
简要总结
Postoperative pancreatic fistula (POPF) is a major complication and an important cause of mortality after pancreaticoduodenectomy (PD). Trans-nasal afferent loop decompression technique (TNALD) may reduce the rate of POPF based on our previous retrospective study. The aim of this open-label randomized controlled trial is to determine whether TNALD is a protective factor against the development of POPF after PD.
详细描述
In our previous retrospective study, decompression of the afferent jejunal and pancreatic and biliary anastomoses with a special nasogastric tube and postoperative continuous closed negative pressure suction was shown to be associated with a reduction in overall POPF rate from 39% to 27% after PD. However, TNALD has the potential theoretical risk of increased morbidity including pulmonary complications and delayed gastric emptying.
The objective of this prospective randomized study is to evaluate the impact of trans-nasal afferent loop decompression on the incidence of complications after PD, especially POPF rate according to International Study Group of Pancreatic Surgery (ISGPS) 2016 updates. We hypothesize that the TNALD may prevent the development of POPF after PD. This study randomizes patients to TNALD versus no TNALD group. Subgroup analysis of the outcomes in different POPF risk groups is also planned.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for elective open pancreaticoduodenectomy with Child reconstruction
- •Age > 18 years and ≤ 85 years
- •Full agreement to participate and written informed consent is given
排除标准
- •Emergent pancreaticoduodenectomy
- •Laparoscopic pancreaticoduodenectomy or robotic pancreaticoduodenectomy, including transition to open approach
- •Participant in other trials of pancreaticoduodenectomy with interfering interventions and/or endpoints
- •Patient with severe co-morbidity(s) before surgery, including severe insufficiency in kidney, heart and/or liver, etc.
- •Patient had medication history of corticosteroids over 3 days during last 30 days before surgery
- •No need for pancreaticojejunostomy during pancreaticoduodenectomy (i.e. past left pancreatectomy, pancreaticogastrostomy, etc.), or pancreatic anastomosis cannot be reconstructed for any reason
- •External stenting is used during the surgery for any reason
- •Nasogastric tube is inserted and kept for postoperative gastric decompression
- •In any situation that the placement of afferent loop decompression tube is medically inappropriate or not infeasible
结局指标
主要结局
Postoperative pancreatic fistula (grade B+C)
时间窗: up to 90 days after surgery
Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.
次要结局
- Overall complication and severe complication(up to 90 days after surgery)
- Pancreatic fistula related complications(up to 90 days after surgery)
- Reintervention treatment(up to 90 days after surgery)
- Other complications(up to 90 days after surgery)
- Mortality rate(up to 90 days after surgery)
- Readmission(up to 90 days after surgery)
- Postoperative new-onset pulmonary complication(up to 14 days after surgery)
- Length of postoperative stay(up to 90 days after surgery)
研究者
Kuirong Jiang
Director of Pancreas Center
The First Affiliated Hospital with Nanjing Medical University