Tissue Oxygen Saturation for Esophagectomy

July 20, 2021 updated by: Kenjiro Ishii, Shizuoka Cancer Center

Tissue Oxygen Saturation During Gastric Tube Reconstruction With Cervical Anastomosis 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Suntogun
  - Nagaizumicho, Suntogun, Japan, 4118111
    - Shizuoka Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This was a retrospective study performed at the Shizuoka Cancer Center between November 2020 and March 2021. All 18 patients who underwent esophagectomy with gastric tube reconstruction were enrolled in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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''.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of anastomotic leakage Time Frame: 1month after surgery	We investigated the rate of anastomotic leakage in the cervical site (0% - 100%).	1month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shizuoka Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

July 3, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)