Efficacy of Routine Staple Line Reinforcement Versus no Reinforcement on Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy: A Single Center, Parallel, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Clinically relevant postoperative pancreatic fistula (CR-POPF)
研究概览
简要总结
Postoperative fistula is the major complications of distal pancreatectomies which prohibit patients' recovery. Previous studies have reported controversial results regarding the efficacy of pancreatic stump reinforcement methods. Prior research has commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult. Data has shown that staple line plus reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Thus, the investigators design the present study to the question that whether routine staple line plus reinforcement would bring benefit for participants.
详细描述
Distal pancreatectomy (DP)is the standard surgical method for benign or malignant pancreatic tumors locating at body and tail [1]. Clinically relevant postoperative pancreatic fistula (CR-POPF) is the major complication after pancreatectomy. In literature, reported CR-POPF rate after distal pancreatectomy varied between 5% and 64% from different centers. It's still a challenge to prevent CR-POPF via effective pancreatic remnant closure and no consensus on the optimal surgical technique has been established. Reported surgical strategies to prevent CR-POPF included stapler transection, staple line reinforcement, stump coverage with autologous tissue or fibrin glue, mesh reinforcement, and prophylactic administration of octreotide. However, none had convincing outcome [2-4].
Data has shown that staple line plus suture reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Meanwhile, prior researches have commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult [5-8].
Thus, the investigators design a single-centered, parallel, randomized controlled trial to compare the efficacy of routine staple line plus reinforcement versus staple only on the CR-POPF rate of participants who underwent minimally invasive distal pancreatectomies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
It will be single blinded. Operator, first assistant and data collector could not be blinded. Whereas patients, nurses, data analyzer, and those who have the access to the primary predictor will be blinded.
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
- •Those who will receive distal pancreatectomy via minimally invasive approaches, no matter benign or malignant;
- •Aged from 18 - 80 years;
- •Preoperative diagnosis of serous or mucinous cystic adenoma;
- •Preoperative diagnosis of solid pseudopapillary tumor (SPT);
- •Preoperative diagnosis of neuroendocrine tumor;
- •Preoperative diagnosis of intraductal papillary mucinous neoplasm (IPMN);
- •Preoperative diagnosis of or pseudocyst;
- •Preoperative diagnosis of distal pancreatic malignancies;
- •Patients willing to provide informed consent.
排除标准
- •History of upper abdominal surgical history such as splenectomy, gastrectomy, liver resection, duodenal or pancreatic resection (not including laparoscopic cystectomy);
- •Pancreatic trauma;
- •With pneumoperitoneum contraindications;
- •With severe heart or pulmonary diseases which is not fit for surgeries.
结局指标
主要结局
Clinically relevant postoperative pancreatic fistula (CR-POPF)
时间窗: Postoperative postoperative day 30.
CR-POPF is defined according to the revised 2016 version of ISGPS (International Study Group on Pancreatic Surgery) classification and grading of POPF. A CR-POPF is defined as a drain output of any measurable volume of fluid with amylase level greater than 3 times the upper Institutional normal serum amylase level, associated with a clinically relevant development/condition related directly to the POPF.
次要结局
- Operative time(Postoperative postoperative day 30.)
- Estimated blood loss(Postoperative postoperative day 30.)
- Length of postoperative hospital stay(Postoperative postoperative day 30.)
研究者
Feng Tian
Attending
Peking Union Medical College Hospital