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Feasibility and Safety of Oral Nutritional Supplementation with High-Density Liquid Diet After Total Gastrectomy for Gastric Cancer

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Abstract

Introduction

Patients requiring total gastrectomy for gastric cancer experience a decrease in food intake leading to severe body weight loss after surgery. This loss may be prevented using a high-density liquid diet of high caloric content and minimal volume. This phase II study evaluated the feasibility and safety of a high-density liquid diet (UpLead®; Terumo Corporation, Tokyo, Japan) after total gastrectomy.

Methods

UpLead® (1 pack, 100 mL, 400 kcal/day) was administered after surgery for 28 days. The primary endpoint was the % relative dose intensity of 28 days of UpLead intake®. The secondary endpoint was % body weight loss at 1 and 3 months after surgery. The sample size was 35 considering expected and threshold values of 80 and 60%, respectively, with a one-sided alpha error of 10% and statistical power of 80%.

Results

Among 35 patients enrolled before surgery between April 2018 and December 2019, 29 patients who could initiate UpLead® after surgery were analyzed. Seven patients had interrupted UpLead® intake due to taste intolerance (n = 6) and due to a duodenal stump fistula (n = 1). The remaining 22 patients completed 28 days of UpLead® intake, including temporary interruption, with no associated adverse events. The median relative dose intensity was 25.8% (95% confidence interval: 20.6–42.0%). The median body weight loss at 1 and 3 months after surgery was 7.2% (range: 3.2–13.9%) and 13.1% (range: 2.5–20.4%), respectively.

Conclusions

Oral nutritional supplementation with a high-density liquid diet (UpLead®) was safely administered but was not feasible after total gastrectomy for gastric cancer.


Clinical trial registration number UMIN000032291.

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Acknowledgements

We thank all the patients, their families, investigators, and medical staff members who participated in this study.

Funding

This work is supported, in part, by Kanagawa Standard Anti-Cancer Therapy Support System (KSATTS).

Author information

Authors and Affiliations

  1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan

    Takanobu Yamada, Hirohito Fujikawa, Yuta Kumazu, Shinsuke Nagasawa, Masato Nakazono, Kazuki Kano, Kentaro Hara, Hayato Watanabe, Keisuke Komori, Yota Shimoda, Kosuke Takahashi, Takashi Ogata & Takashi Oshima

  2. Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan

    Tsutomu Hayashi & Takaki Yoshikawa

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  1. Takanobu Yamada
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Corresponding author

Correspondence to Takaki Yoshikawa.

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Conflict of interest

Dr. Yamada reports personal fees from ONO, personal fees from BMS, personal fees from Johnson and Johnson, personal fees from Taiho, personal fees from Nippon Kayaku, outside the submitted work. Dr. Oshima reports Grants and personal fees from Taiho, Grants and personal fees from Chugai, Grants and personal fees from Ono, Grants from Daiichi Sankyo, Grants and personal fees from Nippon Kayaku, Grants and personal fees from Eli Lilly, personal fees from BMS, outside the submitted work. Dr. Yoshikawa reports personal fees from Taiho, personal fees from Ono, personal fees from BMS, personal fees from Daiichi Sankyo, personal fees from MSD, personal fees from TERUMO, personal fees from Covidien, personal fees from Olympus, personal fees from Johnson and Johnson, personal fees from Chugai, personal fees from Lilly, personal fees from Nihon Kayaku, outside the submitted work. All the remaining authors have no conflicts of interest to declare.

Ethical approval

The study protocol was approved by the institutional review board of Kanagawa Cancer Center (Approval No: 2017–49). The study procedures complied with the recommendations of the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and the guidelines of the responsible Japanese governmental agency.

Informed consent

All patients were required to provide written informed consent before enrollment.

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Yamada, T., Hayashi, T., Fujikawa, H. et al. Feasibility and Safety of Oral Nutritional Supplementation with High-Density Liquid Diet After Total Gastrectomy for Gastric Cancer. World J Surg 46, 2433–2439 (2022). https://doi.org/10.1007/s00268-022-06639-1

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