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

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• 作者：Ken-ichi Okada ; MD^a ; Manabu Kawai ; MD^a ; Seiko Hirono ; MD^a ; Tsutomu Fujii ; MD^b ; Yasuhiro Kodera ; MD^b ; Masayuki Sho ; MD^c ; Yoshiyuki Nakajima ; MD^c ; Sohei Satoi ; MD^d ; A-Hon Kwon ; MD^d ; Yasuhiro Shimizu ; MD^e ; Yoshiyasu Ambo ; MD^f ; Naru Kondo ; MD^g ; Yoshiaki Murakami ; MD^g ; Jiro Ohuchida ; MD^h ; Hidetoshi Eguchi ; MDⁱ ; Hiroaki Nagano ; MDⁱ ; Mari S. Oba ; PhD^j ; Satoshi Morita ; PhD^k ; Junichi Sakamoto ; MD^l ; Hiroki Yamaue ; MD^a ; ^{yamaue-h@wakayama-med.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; the JAPAN-PD Investigators
• 刊名：Surgery
• 出版年：2016
• 出版时间：May 2016
• 年：2016
• 卷：159
• 期：5
• 页码：1333-1341
• 全文大小：227 K

文摘

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.