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Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial

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Abstract

Background

Anastomosis-related complications such as bleeding, leakage, and strictures, continue to be serious complications of gastric cancer surgery. Presently, these complications have yet to be reliably prevented. Here we design a comprehensive leak testing procedure which combines gastroscopy, air, and methylene blue (GAM) leak testing. We aimed to evaluated the efficacy and safety of the GAM procedure in patients with gastric cancer.

Methods

Patients aged 18–85 years without an unresectable factor as confirmed via CT were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital and were randomly assigned to two groups: intraoperative leak testing group (IOLT) and no intraoperative leak testing group (NIOLT). The primary endpoint was the incidence of postoperative anastomosis-related complications in the two groups.

Results

148 patients were initially randomly assigned to the IOLT group (n = 74) and to the NIOLT group (n = 74) between September 2018 and September 2022. After exclusions, 70 remained in the IOLT group and 68 in the NIOLT group. In the IOLT group, 5 patients (7.1%) were found to have anastomotic defects intraoperatively, which included anastomotic discontinuity, bleeding, and strictures. The NIOLT group had a higher incidence of postoperative anastomotic leakage compared to the IOLT group: 4 patients (5.8%) vs 0 patients (0%), respectively. No GAM-related complications were observed.

Conclusion

The GAM procedure is an intraoperative leak test that can be performed safely and efficiently after a laparoscopic total gastrectomy. GAM anastomotic leak testing may effectively prevent technical defect-related anastomotic complications in patients with gastric cancer who undergo a gastrectomy.

Trial registration: Clinical Trials.gov Identifier: NCT04292496.

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Acknowledgements

We thank the support from the Gastrointestinal Surgery Study Group in Nanchong Central Hospital affiliated with North Sichuan Medical College (University). We also thank Dr. Yunhong Tian for his help with the statistical analysis of this study.

Funding

This work was supported by the Foundation of Sichuan Medical Association (S21025) and Cooperative Project of Nanchong City with North Sichuan Medical College (20SXQT0321).

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Authors and Affiliations

  1. Department of General Surgery, The Affiliated Nanchong Central Hospital of North Sichuan Medical College (University), Nanchong, 637000, Sichuan, China

    Zhenguo Gao, Heng Luo, Longyin Ma, Dan Bai, Xiangzhi Qin, Lei Gong, Yong Peng & Yunhong Tian

  2. Department of Radiology, Wayne State University, Detroit, MI, 48201, USA

    Matthew Bautista & Jiani Hu

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  1. Zhenguo Gao
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Contributions

ZG and YT participated in the design of this study, and they both performed the statistical analysis. DB, XQ and YP carried out the study and collected important background information. ZG drafted the manuscript. All authors read and approved the final manuscript. YT, HL and LM carried out the concepts, design, definition of intellectual content, literature search, data acquisition, data analysis and manuscript preparation, LG and YT provided assistance for data acquisition and manuscript editing. MB and JH performed manuscript review. All authors have read and approved the content of the manuscript.

Corresponding author

Correspondence to Yunhong Tian.

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Disclosures

Zhenguo Gao, Heng Luo, Longyin Ma, Dan Bai, Xiangzhi Qin, Matthew Bautista, Lei Gong, Yong Peng, Jiani Hu and Yunhong Tian have no conflicts of interest to disclose.

Human rights statement

All procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the 1964 Declaration of Helsinki and later versions.

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Informed consent for inclusion in the study was obtained from all patients.

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Gao, Z., Luo, H., Ma, L. et al. Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial. Surg Endosc 37, 5265–5273 (2023). https://doi.org/10.1007/s00464-023-10025-w

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  • DOI: https://doi.org/10.1007/s00464-023-10025-w

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