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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Incidence of postoperative paralytic ileus (including the duration of paralysis)
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.
Hiroki Yamaue, M.D., Ph.D.
Second Department of Surgery, Wakayama Medical University
Japan: Institutional Review Board