The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Incidence of delayed gastric emptying (DGE)
研究概览
简要总结
Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life.
Braun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE.
This study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.
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
- •Age ≥ 18 years, male or female;
- •Scheduled to undergo curative pancreaticoduodenectomy (PD);
- •Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction;
- •Mentally competent and able to provide written informed consent.
排除标准
- •Age < 18 years;
- •Prior diagnosis of gastroparesis;
- •Benign disease as the indication for PD;
- •Previous history of upper gastrointestinal surgery;
- •Preoperative pyloric obstruction;
- •Planned pylorus-preserving pancreaticoduodenectomy (PPPD);
- •Patients who have received neoadjuvant or conversion therapy;
- •Preoperative glycated hemoglobin (HbA1c) > 7.5%;
- •Preoperative total bilirubin level > 200 μmol/L;
- •Unable or unwilling to provide written informed consent.
结局指标
主要结局
Incidence of delayed gastric emptying (DGE)
时间窗: Postoperative days 1, 8, 15, and 22
Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
次要结局
- Length of hospital stay (days)(From first postoperative day to hospital discharge up to 15 weeks)
- Treatment cost(From the first postoperative day to one year follow-up)
- Postoperative recovery(From the first postoperative day to one year follow-up)
- Bile reflux(Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.)
- Proportion of severe complications as defined by the Clavien-Dindo classification(From the first postoperative day to one year follow-up)
- Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively(30 days)