Abstract | BACKGROUND/AIMS: METHODOLOGY: 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.
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Authors | Ken-Ichi Okada, Manabu Kawai, Seiko Hirono, Motoki Miyazawa, Atsushi Shimizu, Yuji Kitahata, Hiroki Yamaue |
Journal | Hepato-gastroenterology
(Hepatogastroenterology)
2015 Mar-Apr
Vol. 62
Issue 138
Pg. 466-71
ISSN: 0172-6390 [Print] Greece |
PMID | 25916084
(Publication Type: Controlled Clinical Trial, Journal Article)
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Chemical References |
- Gastrointestinal Agents
- IL10 protein, human
- IL9 protein, human
- Interleukin-9
- Plant Extracts
- dai-kenchu-to
- Interleukin-10
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Topics |
- Digestive System Neoplasms
(surgery)
- Drug Administration Schedule
- Female
- Gastrointestinal Agents
(administration & dosage, adverse effects)
- Hospitals, University
- Humans
- Interleukin-10
(blood)
- Interleukin-9
(blood)
- Intestinal Pseudo-Obstruction
(blood, diagnosis, etiology, prevention & control)
- Japan
- Male
- Panax
- Pancreaticoduodenectomy
(adverse effects)
- Pilot Projects
- Plant Extracts
(administration & dosage, adverse effects)
- Prospective Studies
- Quality of Life
- Surveys and Questionnaires
- Time Factors
- Treatment Outcome
- Zanthoxylum
- Zingiberaceae
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