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

Area of Science:

• Surgical Oncology
• Gastroenterology
• Medical Devices

Background:

• Anastomotic leakage is a risk after radical esophagectomy due to insufficient blood flow.
• Previous case series suggested tissue oxygen saturation monitoring could be useful.
• This prospective study aimed to validate the use of a tissue oxygen saturation monitor.

Purpose of the Study:

• To evaluate the feasibility of monitoring regional tissue oxygen saturation (rSO2) during radical esophagectomy.
• To determine if rSO2 levels correlate with anastomotic leakage at the cervical anastomosis site.
• To assess the predictive value of rSO2 for gastric tube viability.

Main Methods:

• A single-arm phase II study enrolled 42 patients undergoing radical esophagectomy with gastric tube reconstruction.
• Regional tissue oxygen saturation (rSO2) was measured at multiple points before and after gastric tube elevation.
• The primary endpoint was achieving rSO2 > 45% at the anastomotic site; secondary endpoints examined rSO2 changes and leakage correlation.

Main Results:

• 83.3% of patients achieved the primary endpoint of rSO2 > 45% at the anastomotic site.
• Anastomotic leakage occurred in seven patients.
• Significantly lower rSO2 at the gastric tube tip after elevation was observed in patients who developed leakage.

Conclusions:

• Tissue oxygen saturation monitoring is a feasible method to assess gastric tube blood flow during radical esophagectomy.
• Low rSO2 levels, particularly at the tip post-elevation, may indicate blood flow insufficiency and predict anastomotic leakage.
• This monitoring technique can aid surgeons in identifying at-risk anastomoses.