Effect of Daikenchuto (TJ-100) on postoperative bowel motility and on prevention of paralytic ileus after pancreaticoduodenectomy: a multicenter, randomized, placebo-controlled phase II trial (the JAPAN-PD study).
We conducted a multicenter, randomized, controlled trial in patients with pancreaticoduodenectomy to investigate the efficacy of Daikenchuto (TJ-100), which is a Kampo medicine (traditional Japanese herbal medicine), for its effect on postoperative bowel motility and for prevention of postoperative paralytic ileus. This clinical trial primarily evaluates the co-primary endpoints: (i) the incidence rate of postoperative paralytic ileus lasting over 72 h after surgery and (ii) time to having the first postoperative passage of flatus. The secondary endpoints are the incidence of postoperative paralytic ileus in cases that combined with/without enteral alimentation, QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change ratio of abdominal circumference, the incidence of postoperative complication, the number of postoperative hospital days, the incidence of surgical site infection and the incidence of postoperative small bowel obstruction within 2 years after surgery. Two hundred and twenty patients are required in the study (110 patients per group).
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Ken-ichi
K
Okada
Manabu
M
Kawai
Katsuhiko
K
Uesaka
Yasuhiro
Y
Kodera
Hiroaki
H
Nagano
Yoshiaki
Y
Murakami
Satoshi
S
Morita
Junichi
J
Sakamoto
Hiroki
H
Yamaue
D000328:Adult; D004311:Double-Blind Method; D005769:Gastrointestinal Motility / Q000187:drug effects*; D006801:Humans; D007418:Intestinal Pseudo-Obstruction / Q000517:prevention & control*; D007902:Length of Stay; D005894:Panax; D016577:Pancreaticoduodenectomy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control; D011788:Quality of Life; D013530:Surgical Wound Infection / Q000517:prevention & control; D032106:Zanthoxylum; D030521:Zingiberaceae
D010936:Plant Extracts; C121414:dai-kenchu-to