A Prospective Randomized Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Postoperative Delayed Gastric Emptying and Nutritional Status
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 394
- 主要终点
- Incidence of delayed gastric emptying
研究概览
简要总结
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Recently, pylorus resecting pancreaticoduodenectomy has been actively performed because some studies reported that the procedure can reduce postoperative delayed gastric emptying.
However, the level of evidence is low and there was few studies considering nutritional status after pylorus resecting pancreaticoduodenectomy.
The purpose of this study is to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status.
详细描述
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. It can lead to delay initiation of adjuvant chemotherapy as well as postoperative recovery. Since 2010, pylorus resecting pancreaticoduodenectomy was introduced to reduce postoperative delayed gastric emptying. The cases have been actively increased. However, several prospective randomized controlled trials reported pylorus resection during pancreaticoduodenectomy did not reduce the incidence or severity of delayed gastric emptying. Recent meta-analysis also showed same results.
Previous randomized controlled trials were single center studies participating a relatively small number of patients. A large-scale multicenter study is needed to obtain high level of evidence. And nutritional difference may appear between pylorus preservation and resection groups. Few studies have dealt with nutritional status between two groups.
- This study aimed to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status in 5 tertiary referral centers in Korea..
- A case of pancreaticoduodenectomy with periampullary benign and malignant tumors will be included. The expected number of patients is 394. The pylorus resecting group was performed in the experimental group and the pylorus preserving group was performed in control group.
This clinical study is a randomized prospective comparative study of the outcome of pylorus resecting and preserving pancreatoduodenectomy, and the research hypothesis is as follows.
- Nursing Hypothesis: There is no difference in incidence of delayed gastric emptying between patients who underwent pylorus resecting pancreaticoduodenectomy and patients who underwent pylorus preserving surgery.
- Alternative Hypothesis: Based on the results of the same operation of the existing institution, the average incidence of delayed gastric emptying for pylorus preserving pancreaticoduodenectomy is estimated to be 20%, and the average incidence of delayed gastric emptying for pylorus resecting pancreaticoduodenectomy is estimated to be 10%.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 79 years
- •Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- •The preoperative examination showed that the lesion could invade to major artery.
- •No distant metastasis
- •Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
- •Liver function : aspartate transaminase (AST)/alanine transaminase(ALT) less than 3 times upper limit of normal
- •Kidney function: Creatinine no greater than 1.5 times upper limit of normal.
- •Patients who consented to and signed the consent
排除标准
- •Patients diagnosed with duodenal cancer
- •Those with active or uncontrolled infections
- •Those with severe psychiatric / neurological disorders
- •Alcohol or other drug addicts
- •Patients who underwent previous major abdominal surgery (ex. gastrectomy, colectomy)
- •Patients included in other clinical studies that may affect this study
- •Patients who cannot follow the directions of the researcher
- •Those with uncontrolled heart disease
- •Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (ex. cirrhosis, chronic kidney failure, heart failure, etc.)
- •Pelvic tumor, benign tumor, malignant tumor in other organs
- •Patients who received prior chemotherapy
- •In addition to the planned pancreaticoduodenectomy, patients who require resection of other major abdominal organs, such as gastrectomy, colectomy
结局指标
主要结局
Incidence of delayed gastric emptying
时间窗: up to 1 months
Delayed gastric emptying(DGE) is defined by International Study Group of Pancreas Surgery(ISGPS) definition. * Grade A DGE should be considered if the Nasogastric tube(NGT) is required between the Postoperative Day(POD) 4 and 7, or if reinsertion of the NGT was necessary owing to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but resumes a solid diet before Postoperative Day(POD)14 \*\* Grade B DGE is present if the NGT is required from POD 8-14, if reinsertion of the NGT was necessary after POD 7, or if the patient cannot tolerate unlimited oral intake by Postoperative Day(POD)14, but is able to resume a solid oral diet before POD 21 \*\*\* Grade C DGE is present when nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21
次要结局
- Sarcopenia(up to 12 months)
- Nutritional risk index(NRI)(up to 12 months)
研究者
Song Cheol Kim
Professor
Asan Medical Center