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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).

Abstract

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).

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  • Authors+Show Affiliations

    ,

    Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.

    , , , , , , , ,

    Source

    MeSH

    Adult
    Double-Blind Method
    Gastrointestinal Motility
    Humans
    Intestinal Pseudo-Obstruction
    Length of Stay
    Pancreaticoduodenectomy
    Plant Extracts
    Postoperative Complications
    Quality of Life
    Surgical Wound Infection

    Pub Type(s)

    Clinical Trial, Phase II
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    23365113

    Citation

    Okada, Ken-ichi, et al. "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)." Japanese Journal of Clinical Oncology, vol. 43, no. 4, 2013, pp. 436-8.
    Okada K, Kawai M, Uesaka K, et al. 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). Jpn J Clin Oncol. 2013;43(4):436-8.
    Okada, K., Kawai, M., Uesaka, K., Kodera, Y., Nagano, H., Murakami, Y., ... Yamaue, H. (2013). 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). Japanese Journal of Clinical Oncology, 43(4), pp. 436-8. doi:10.1093/jjco/hyt005.
    Okada K, et al. 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). Jpn J Clin Oncol. 2013;43(4):436-8. PubMed PMID: 23365113.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - 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). AU - Okada,Ken-ichi, AU - Kawai,Manabu, AU - Uesaka,Katsuhiko, AU - Kodera,Yasuhiro, AU - Nagano,Hiroaki, AU - Murakami,Yoshiaki, AU - Morita,Satoshi, AU - Sakamoto,Junichi, AU - Yamaue,Hiroki, AU - ,, Y1 - 2013/01/30/ PY - 2013/2/1/entrez PY - 2013/2/1/pubmed PY - 2013/5/22/medline SP - 436 EP - 8 JF - Japanese journal of clinical oncology JO - Jpn. J. Clin. Oncol. VL - 43 IS - 4 N2 - 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). SN - 1465-3621 UR - https://www.unboundmedicine.com/medline/citation/23365113/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__ L2 - https://academic.oup.com/jjco/article-lookup/doi/10.1093/jjco/hyt005 DB - PRIME DP - Unbound Medicine ER -