Effect of Daikenchuto (TJ-100) on Intestinal Dysmotility and For the Prevention of Postoperative Paralytic Ileus in Patients Undergoing Pancreaticoduodenectomy: A Multicenter, Randomized, Placebo-Controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- The duration until the first flatus after surgery.
研究概览
简要总结
A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.
详细描述
Daikenchuto (TJ-100), a traditional Japanese herbal medicine, is used for prevention and treatment of postoperative ileus. TJ-100 extract powder (Tsumura & Co., Tokyo, Japan) is manufactured as an aqueous extract containing 2.2 % Japanese pepper, 5.6 % processed ginger, 3.3 % ginseng, and 88.9 % maltose syrup powder. A recent randomized, parallel-group, double-blind, placebo-controlled, dose-response trial demonstrated that TJ-100 accelerates colonic transit time, particularly in the ascending colon. Given its potential actions in the intestinal tract, it seems reasonable to postulate that TJ-100 may play a role in improving and preventing bowel dysmotility. This study was designed to investigate the effect of TJ-100 on intestinal dysmotility and for the prevention of postoperative paralytic ileus in patients undergoing pancreaticoduodenectomy.
The primary endpoint is the incidence of postoperative paralytic ileus. Secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change in ratio of abdominal circumference, the incidence of postoperative complications, the length of hospital day, and the incidence of surgical site infection. Two hundred patients are required for the study (100 patients per group).
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with periampullary tumors (extrahepatic bile duct tumor, tumors of ampulla of Vater and duodenal tumor) and pancreatic tumors (pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, pancreatic endocrine tumor and pancreatic neuroendocrine tumor) of the head of the pancreas who are scheduled to undergo PD.
- •Age of at least 20 years old at the time of registration.
- •All patients provided written informed consent before initiation of study-related procedures.
排除标准
- •Clinically problematic cardiac disease.
- •Liver cirrhosis or active hepatitis.
- •Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.).
- •Chronic renal failure requiring hemodialysis.
- •Other malignant disease that can influence the adverse effect.
- •Patients with tumors requiring resection of colon.
- •Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history.
- •Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants.
- •Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration.
- •Pregnant or lactating women.
- •Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
研究组 & 干预措施
Oral/enteral TJ-100 solution
Oral/enteral TJ-100 solution
干预措施: Oral/enteral TJ-100 solution (Drug)
Oral/enteral placebo solution
Oral/enteral placebo solution
干预措施: Oral/enteral placebo solution (Drug)
结局指标
主要结局
The duration until the first flatus after surgery.
时间窗: 14 days
The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.
Incidence of postoperative paralytic ileus (including the duration of paralysis)
时间窗: 72 hours
Delayed passage of first flatus for 72 hours (3.0 days) after surgery, or a postoperative condition that requires an intervention for the ileus. Every 12 hours is counted as 0.5 postoperative day and every 24 hours as 1.0 postoperative day.
次要结局
- Abdominal pain and abdominal distention scores on the Visual Analogue Scale.(3 days)
- The long term incidence of postoperative ileus after surgery.(2 years)
- The incidence of postoperative complication.(14 days)
- QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)(7 days)
- The incidence of surgical site infection.(30 days)
- The change ratio of abdominal circumference.(3 days)
- The length of postoperative hospital day.(30 days)
研究者
Hiroki Yamaue
Professor
Wakayama Medical University