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.

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).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.