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Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial.

Abstract

BACKGROUND

We assessed the efficacy of TJ-100 taken perioperatively to recovery among patients with periampullary tumor or tumor of the head of the pancreas who underwent pancreaticoduodenectomy (PD).

PATIENTS AND METHODS

In this multicenter, randomized, double-blinded, placebo-controlled, phase II trial (JAPAN-PD Study), patients were assigned randomly in a 1:1 ratio to receive TJ-100 or placebo. The coprimary endpoints were (1) incidence of postoperative paralytic ileus lasting >72 hours after surgery and (2) time to occurrence of postoperative paralytic ileus. This trial is registered at the UMIN Clinical Trials Registry (000007975) and at ClinicalTrials.gov (NCT01607307).

RESULTS

From August 2012 through July 2013, we assessed 273 patients for eligibility, and 224 underwent randomization; 112 patients received TJ-100, and 112 patients received placebo. The population for analysis consisted of 104 patients who received TJ-100 and 103 who received placebo. Paralytic ileus occurred 35 (33.7%) in the TJ-100 group and 38 (36.9%) in the placebo group (P = .626). Time to first flatus was 2.25 (2.00-2.50) days in the TJ-100 group and 2.50 (1.50-2.50) days in the placebo group (P = .343). Among 23 patients who underwent a pylorus ring-preserving PD, time to first flatus was lower in the TJ-100 group than in the placebo group: 0.50 (0.50-1.00) days versus 1.50 (0.50-3.00) days (P = .034).

CONCLUSION

Our findings suggest that use of TJ-100 did not improve recovery from paralytic ileus after PD, and may preclude the routine use of TJ-100 in clinical practice after PD operation.

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  • Authors+Show Affiliations

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

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

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

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    Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.

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    Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.

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    Department of Surgery, Nara Medical University, Kashihara, Japan.

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    Department of Surgery, Nara Medical University, Kashihara, Japan.

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    Department of Surgery, Kansai Medical University, Hirakata, Japan.

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    Department of Surgery, Kansai Medical University, Hirakata, Japan.

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    Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.

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    Department of Surgery, Teine-keijinkai Hospital, Sapporo, Japan.

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    Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

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    Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

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    Department of Surgical Oncology and Regulation of Organ Function, Miyazaki University School of Medicine, Miyazaki, Japan.

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    Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.

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    Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.

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    Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan.

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    Department of Biomedical Statistical and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.

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    Tokai Central Hospital, Kakamigahara, Japan.

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    Second Department of Surgery, Wakayama Medical University, Wakayama, Japan. Electronic address: yamaue-h@wakayama-med.ac.jp.

    Source

    Surgery 159:5 2016 May pg 1333-41

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Double-Blind Method
    Drug Administration Schedule
    Female
    Gastrointestinal Agents
    Humans
    Incidence
    Intestinal Pseudo-Obstruction
    Kaplan-Meier Estimate
    Logistic Models
    Male
    Middle Aged
    Pancreatic Neoplasms
    Pancreaticoduodenectomy
    Perioperative Care
    Plant Extracts
    Postoperative Complications
    Proportional Hazards Models
    Treatment Outcome

    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

    26747224

    Citation

    Okada, Ken-ichi, et al. "Evaluation of the Efficacy of Daikenchuto (TJ -100) for the Prevention of Paralytic Ileus After Pancreaticoduodenectomy: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial." Surgery, vol. 159, no. 5, 2016, pp. 1333-41.
    Okada K, Kawai M, Hirono S, et al. Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial. Surgery. 2016;159(5):1333-41.
    Okada, K., Kawai, M., Hirono, S., Fujii, T., Kodera, Y., Sho, M., ... Yamaue, H. (2016). Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial. Surgery, 159(5), pp. 1333-41. doi:10.1016/j.surg.2015.11.019.
    Okada K, et al. Evaluation of the Efficacy of Daikenchuto (TJ -100) for the Prevention of Paralytic Ileus After Pancreaticoduodenectomy: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial. Surgery. 2016;159(5):1333-41. PubMed PMID: 26747224.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial. AU - Okada,Ken-ichi, AU - Kawai,Manabu, AU - Hirono,Seiko, AU - Fujii,Tsutomu, AU - Kodera,Yasuhiro, AU - Sho,Masayuki, AU - Nakajima,Yoshiyuki, AU - Satoi,Sohei, AU - Kwon,A-Hon, AU - Shimizu,Yasuhiro, AU - Ambo,Yoshiyasu, AU - Kondo,Naru, AU - Murakami,Yoshiaki, AU - Ohuchida,Jiro, AU - Eguchi,Hidetoshi, AU - Nagano,Hiroaki, AU - Oba,Mari S, AU - Morita,Satoshi, AU - Sakamoto,Junichi, AU - Yamaue,Hiroki, AU - ,, Y1 - 2015/12/31/ PY - 2015/10/04/received PY - 2015/11/18/revised PY - 2015/11/27/accepted PY - 2016/1/10/entrez PY - 2016/1/10/pubmed PY - 2016/8/16/medline SP - 1333 EP - 41 JF - Surgery JO - Surgery VL - 159 IS - 5 N2 - BACKGROUND: We assessed the efficacy of TJ-100 taken perioperatively to recovery among patients with periampullary tumor or tumor of the head of the pancreas who underwent pancreaticoduodenectomy (PD). PATIENTS AND METHODS: In this multicenter, randomized, double-blinded, placebo-controlled, phase II trial (JAPAN-PD Study), patients were assigned randomly in a 1:1 ratio to receive TJ-100 or placebo. The coprimary endpoints were (1) incidence of postoperative paralytic ileus lasting >72 hours after surgery and (2) time to occurrence of postoperative paralytic ileus. This trial is registered at the UMIN Clinical Trials Registry (000007975) and at ClinicalTrials.gov (NCT01607307). RESULTS: From August 2012 through July 2013, we assessed 273 patients for eligibility, and 224 underwent randomization; 112 patients received TJ-100, and 112 patients received placebo. The population for analysis consisted of 104 patients who received TJ-100 and 103 who received placebo. Paralytic ileus occurred 35 (33.7%) in the TJ-100 group and 38 (36.9%) in the placebo group (P = .626). Time to first flatus was 2.25 (2.00-2.50) days in the TJ-100 group and 2.50 (1.50-2.50) days in the placebo group (P = .343). Among 23 patients who underwent a pylorus ring-preserving PD, time to first flatus was lower in the TJ-100 group than in the placebo group: 0.50 (0.50-1.00) days versus 1.50 (0.50-3.00) days (P = .034). CONCLUSION: Our findings suggest that use of TJ-100 did not improve recovery from paralytic ileus after PD, and may preclude the routine use of TJ-100 in clinical practice after PD operation. SN - 1532-7361 UR - https://www.unboundmedicine.com/medline/citation/26747224/Evaluation_of_the_efficacy_of_daikenchuto__TJ__100__for_the_prevention_of_paralytic_ileus_after_pancreaticoduodenectomy:_A_multicenter_double_blind_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0039-6060(15)00966-6 DB - PRIME DP - Unbound Medicine ER -