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 n id="intref0010" class="interref" data-locatorType="url" data-locatorKey="http://ClinicalTrials.gov">ClinicalTrials.govn> (n id="intref0015" class="interref" data-locatorType="ctgov" data-locatorKey="NCT01607307">NCT01607307n>).

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.