Abstract
Background
Esophagogastric variceal bleeding is the most common lethal factor for patients with cirrhotic portal hypertension. We firstly developed a laparoscopic splenectomy and azygoportal disconnection (LSD) with intraoperative endoscopic variceal ligation (LSDL) technique. In this study, we aimed to evaluate whether LSDL is feasible and safe and whether LSDL can effectively prevent esophagogastric variceal re-bleeding (EVR), as compared with single LSD.
Methods
In this randomized controlled single-center study, 88 patients with cirrhosis who had esophagogastric variceal bleeding and hypersplenism were randomly assigned to receive either LSD (n = 44) or LSDL (n = 44) between January 2020 and December 2021. The primary outcome was EVR.
Results
No patients withdrew from the study. There were no significant differences in estimated blood loss, incidence of blood transfusion, time to first flatus and off-bed activity, or postoperative hospital stay between the two groups. Compared with that in the LSD group, operation time was significantly longer in the LSDL group (138.5 ± 19.4 min vs. 150.3 ± 19.0 min, P < 0.05); however, LSDL was associated with a significantly decreased EVR rate at 1-year follow-up (8/44 vs. 1/44, P < 0.05). Univariate analysis and multivariate logistic regression revealed that LSDL was a significant independent protective factor against EVR in comparison with LSD (relative risk: 0.105, 95% confidence interval 0.012–0.877; P = 0.037).
Conclusions
Our newly developed LSDL procedure is not only technically feasible and safe; it also contributed to lowering the EVR risk more so than single LSD.
Trial Registration
We registered our research at https://www.clinicaltrials.gov/. The name of research registered is “Laparoscopic Splenectomy and Azygoportal Disconnection with Intraoperative Endoscopic Variceal Ligation.” The trial registration identifier at clinicaltrials.gov is NCT04244487.
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Funding
This work was supported by Six Talent Peaks Project in Jiangsu Province (No. WSW-230) and Yangzhou City Social Development Project (YZ2021077).
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DS Bai, SJ Jin, and XX Xiang: project development, data collection or management, data analysis and collection, and manuscript writing. JJ Qian, C Zhang, SJ Jin, BH Zhou, and TM Gao: project development, data collection or management, and manuscript writing. GQ Jiang: project development, data analysis, and manuscript editing. All authors reviewed the manuscript.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The research was approved by the author’s university ethics review board. The research was approved by the author’s university ethics review board. The reference number is no. 2019116.
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Bai, DS., Jin, SJ., Xiang, XX. et al. Vagus Nerve–Preserving Laparoscopic Splenectomy and Azygoportal Disconnection with Versus Without Intraoperative Endoscopic Variceal Ligation: a Randomized Clinical Trial. J Gastrointest Surg 26, 1838–1845 (2022). https://doi.org/10.1007/s11605-022-05374-1
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DOI: https://doi.org/10.1007/s11605-022-05374-1