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Impact of Energy Devices During Liver Parenchymal Transection: A Multicenter Randomized Controlled Trial

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Abstract

Objective

To clarify the benefit of energy devices such as ultrasonically activated device and bipolar vessel sealing device in liver surgeries.

Background

Several studies have suggested the benefit of energy devices in liver transection, while a randomized trial has found no association between their use and surgical outcomes.

Patients and methods

Patients scheduled to undergo open liver resection were eligible for this multicenter non-blinded randomized study. They were randomized to receive an energy device (experimental group) or not (control group) during liver transection. The primary endpoint was the proportion of patients with intraoperative blood loss >1,000 mL. The primary aim was to show non-inferiority of hepatectomy with energy device to that without energy device.

Results

A total of 212 patients were randomized and 211 (105 and 106 in the respective groups) were analyzed. Intraoperative blood loss >1,000 mL occurred in 15.0 % patients with energy device and 20.2 % patients without energy device. The experimental minus control group difference was −5.2 % (95 % confidence interval −13.8 to 3.3 %; non-inferiority test, p = 0.0248). Hepatectomy with energy device resulted in a shorter median liver transection time (63 vs. 84 min; p < 0.001) and a lower rate of postoperative bile leakage (4 vs. 16 %; p = 0.002).

Conclusions

The hypothesis that hepatectomy with energy device is not inferior to that without energy device in terms of blood loss has been demonstrated. The use of energy devices during liver surgery is clinically meaningful as it shortens the liver transection time and reduces the incidence of postoperative bile leakage.

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Acknowledgments

The authors express deep gratitude to Dr. Tomoo Kosuge for his help and encouragement. We thank Drs. Junichi Arita, Takashi Mizuno, and Shutaro Hori for their various supports. Finally, we thank all patients and their families who participated in this study.

Disclosure

This study was supported by a grant-in-aid for Cancer Research from the Ministry of Health, Welfare, and Labor of Japan (21-7-5).

Conflicts of interest

The authors declare that they have no conflicts of interest to disclose.

Author information

Authors and Affiliations

  1. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Naoto Gotohda & Masaru Konishi

  2. Department of Biostatistics, Yokohama City University, Yokohama, Japan

    Takeharu Yamanaka

  3. Department of Gastrointestinal Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

    Akio Saiura

  4. Department of Hepato-Biliary-Pancreatic Surgery, Sizuoka Cancer Center Hospital, Shizuoka, Japan

    Katsuhiko Uesaka

  5. Department of Digestive Surgery, Toranomon Hospital, Tokyo, Japan

    Masaji Hashimoto

  6. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Tokyo, Japan

    Kazuaki Shimada

Authors
  1. Naoto Gotohda
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  2. Takeharu Yamanaka
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  3. Akio Saiura
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  4. Katsuhiko Uesaka
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  5. Masaji Hashimoto
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  6. Masaru Konishi
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  7. Kazuaki Shimada
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Corresponding author

Correspondence to Naoto Gotohda.

Additional information

UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm): UMIN000006044.

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Gotohda, N., Yamanaka, T., Saiura, A. et al. Impact of Energy Devices During Liver Parenchymal Transection: A Multicenter Randomized Controlled Trial. World J Surg 39, 1543–1549 (2015). https://doi.org/10.1007/s00268-015-2967-y

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  • DOI: https://doi.org/10.1007/s00268-015-2967-y

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