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NCT04973046 Clinical Trial

Tissue Oxygen Saturation for Esophagectomy

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04973046
Other study ID # ShizuokaCC rSO2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date April 30, 2021

Study information
Verified date July 2021
Source Shizuoka Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date April 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Shizuoka cancer center Nagaizumicho Suntogun

Sponsors (1)
Lead Sponsor Collaborator
Shizuoka Cancer Center

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The tissue oxygen saturation score of gastric tube during esophagectomy We measured the tissue oxygen saturation (0% - 99%) of several parts of gastric tube during esophagectomy with a use of tissue saturation monitor ''toccare''. During surgery
Secondary The rate of anastomotic leakage We investigated the rate of anastomotic leakage in the cervical site (0% - 100%). 1month after surgery
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