Perioperative administration of Daikenchuto (TJ-100) reduces the postoperative paralytic ileus in patients with pancreaticoduodenectomy.
OBJECTIVE
No study has reported whether perioperative administration of Daikenchuto (TJ-100) reduced paralytic ileus after pancreaticoduodenectomy (PD).


METHODS
Forty-five consecutive patients that were scheduled to undergo PD at Wakayama Medical University Hospital between August 2010 and August 2011 were enrolled in this study including the first cohort (n = 15) as the control group and the subsequent cohort (n = 30) as the TJ-100 group. This trial was registered at UMIN-CTR ID# 000005056.


RESULTS
Postoperative paralytic ileus occurred more frequently in the control group (73.3% of the control group and 20.0% of the TJ-100 group; p = 0.001). The first passages of flatus significantly improved earlier in the TJ-100 group than in the control group (p = 0.014). A multiple cytokine assay of the drainage and serum showed that IL-9 and IL-10 in the drainage was significantly higher on postoperative day 1 in the TJ-100 group. There were no complications associated with the preoperative administration of TJ-100 before surgery, and no significant differences were observed between the two groups in the incidence of postoperative Gradel-2 diarrhea (CTCAE4.0).


CONCLUSIONS
Perioperative administration of TJ-100 was feasible and reduced the incidence of paralytic ileus in PD, and further randomized controlled trials should be conducted.
Ken-Ichi
K
Okada
Manabu
M
Kawai
Seiko
S
Hirono
Motoki
M
Miyazawa
Atsushi
A
Shimizu
Yuji
Y
Kitahata
Hiroki
H
Yamaue
D004067:Digestive System Neoplasms / Q000601:surgery*; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006785:Hospitals, University; D006801:Humans; D016753:Interleukin-10 / Q000097:blood; D016906:Interleukin-9 / Q000097:blood; D007418:Intestinal Pseudo-Obstruction / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D007564:Japan; D008297:Male; D005894:Panax; D016577:Pancreaticoduodenectomy / Q000009:adverse effects*; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D032106:Zanthoxylum; D030521:Zingiberaceae
D005765:Gastrointestinal Agents; C508609:IL10 protein, human; C508607:IL9 protein, human; D016906:Interleukin-9; D010936:Plant Extracts; C121414:dai-kenchu-to; D016753:Interleukin-10