Tissue Oxygen Saturation for Esophagectomy

Completed

• Conditions: Oxygen Deficiency; Esophagostomy Complication; Esophageal Neoplasms; Anastomotic Leak

• Registration Number: NCT04973046
• Lead Sponsor: Shizuoka Cancer Center

Brief Summary

Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.

Detailed Description

One cause of anastomotic leakage after radical esophagectomy is blood flow insufficiency at the cervical anastomosis site. .

Eighteen patients, who underwent radical esophagectomy with gastric tube reconstruction, were studied. The regional tissue oxygen saturation (rSO2) was measured at the tip (point pre 0) and 2, 4, and 6 cm on the anal side of the tip (point pre 1, pre 2, and pre 3, respectively) before the gastric tube was raised to the cervical site through the retrosternal route. After that, rSO2 was measured at the tip, 2 and 4 cm on the anal side of the tip (points post 0, post 1, and post 2), the actual anastomotic site (point AN), and the chest skin as an indicator of whole-body oxygenation . The relationship between rSO2 scores and the rate of anastomotic leakage was determined.

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients who underwent esophagectomy with gastric tube reconstruction from November 2020 to March 2021.

Exclusion Criteria

• Patients who underwent esophagectomy with jejunum or colon reconstruction. patients who underwent two-stage operation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The tissue oxygen saturation score of gastric tube during esophagectomy	During surgery	We measured the tissue oxygen saturation (0% - 99%) of several parts of gastric tube during esophagectomy with a use of tissue saturation monitor ''toccare''.

Secondary Outcome Measures

Name	Time	Method
The rate of anastomotic leakage	1month after surgery	We investigated the rate of anastomotic leakage in the cervical site (0% - 100%).

Trial Locations

Locations (1)

Shizuoka cancer center; 🇯🇵 Nagaizumicho, Suntogun, Japan