Single-Arm Phase Ⅱ Study About a Tissue Oxygen Saturation Monitor in Gastric Tube Reconstruction

IF 1.6 3区医学 Q2 SURGERY

Journal of Surgical Research Pub Date : 2026-02-01 Epub Date: 2025-12-30 DOI:10.1016/j.jss.2025.12.002

Kenjiro Ishii MD, PhD , Yasuhiro Tsubosa MD, PhD , Shuhei Mayanagi MD, PhD , Keita Mori PhD , Masazumi Inoue MD, PhD , Kazunori Tokizawa MD , Ryoma Haneda MD

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引用次数: 0

Abstract

Introduction

Insufficient blood flow at the cervical anastomosis site can cause anastomotic leakage following radical esophagectomy. Previously, we reported the use of a tissue oxygen saturation monitor in a case series study, and we aimed to present the results of the prospective study.

Methods

This single-arm phase Ⅱ study involved patients who underwent radical esophagectomy with gastric tube reconstruction and cervical site anastomosis. Regional tissue oxygen saturation (rSO2) was measured at the tip and 2, 4, and 6 cm on the caudal side of the tip before gastric tube elevation through the retrosternal route. After elevating the gastric tube, rSO2 was measured at the same points: 3 cm above the edge of the sternal bone and the chest skin. The primary endpoint was the rate of having rSO2 > 45% 3 cm above the edge of the sternal bone, which was the anastomotic site. The secondary endpoint was the relationship between anastomotic leakage and the rate of change in rSO2 before and after gastric tube elevation. Based on the calculated sample size, 42 patients were enrolled.

Results

The rate of having rSO2 > 45% 3 cm above the edge of the sternal bone was 83.3%. Anastomotic leakage was found in seven patients. Only the rSO2 at the tip after gastric tube elevation was significantly lower in patients with anastomotic leakage.

Conclusions

Monitoring tissue oxygen saturation was a feasible indicator of blood flow insufficiency in the gastric tube during radical esophagectomy.

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单臂期Ⅱ组织氧饱和度监测仪在胃管重建中的应用研究

食管根治性切除术后，吻合口血流不足可引起吻合口漏。之前，我们报道了在一个病例系列研究中使用组织氧饱和度监测仪，我们的目的是呈现前瞻性研究的结果。方法单臂期Ⅱ研究纳入行根治性食管切除术合并胃管重建和颈部吻合的患者。在经胸骨后途径提升胃管前，在尖端和尖端尾侧2、4和6 cm处测量区域组织氧饱和度（rSO2）。抬高胃管后，在胸骨和胸部皮肤边缘以上3cm处测量rSO2。主要终点为吻合口胸骨边缘以上3cm处rSO2 >； 45%。次要终点为胃管抬高前后吻合口漏与rSO2变化率的关系。根据计算的样本量，纳入42例患者。结果胸骨缘以上3cm处病变发生率为83.3%；吻合口瘘7例。吻合口瘘患者只有胃管抬高后尖端的rSO2明显降低。结论监测组织血氧饱和度是根治性食管切除术中胃管血流不足的一个可行指标。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Surgical Research 医学-外科

CiteScore

3.90

自引率

4.50%

发文量

627

审稿时长

138 days

期刊介绍： The Journal of Surgical Research: Clinical and Laboratory Investigation publishes original articles concerned with clinical and laboratory investigations relevant to surgical practice and teaching. The journal emphasizes reports of clinical investigations or fundamental research bearing directly on surgical management that will be of general interest to a broad range of surgeons and surgical researchers. The articles presented need not have been the products of surgeons or of surgical laboratories. The Journal of Surgical Research also features review articles and special articles relating to educational, research, or social issues of interest to the academic surgical community.