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Completed

NCT Number: NCT04973046

Tissue Oxygen Saturation for Esophagectomy

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

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Key information

Conditions

Esophageal Neoplasms Anastomotic Leak Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophagostomy Complication Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hypoxia Neoplasms Neoplasms by Site Oxygen Deficiency Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Primary location

Shizuoka cancer center

Nagaizumicho, Suntogun, 4118111, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The tissue oxygen saturation score of gastric tube during esophagectomy

    Time frame: 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 outcomes

  1. The rate of anastomotic leakage

    Time frame: 1month after surgery

    We investigated the rate of anastomotic leakage in the cervical site (0% - 100%).

Sponsors and collaborators

Lead sponsor

Shizuoka Cancer Center

Other

Registry information

Official study title

Tissue Oxygen Saturation During Gastric Tube Reconstruction With Cervical Anastomosis for Esophagectomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 22, 2021
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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