NCT04973046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 3, 2021

Last Update Submit

July 20, 2021

Conditions

Esophageal NeoplasmsEsophagostomy ComplicationAnastomotic LeakOxygen Deficiency

Keywords

Esophagectomy, Tissue oxygen saturation, Gastric tube, Anastomotic leakage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The rate of anastomotic leakage

    1month after surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shizuoka cancer center

Nagaizumicho, Suntogun, 4118111, Japan

Location

MeSH Terms

Conditions

Esophageal NeoplasmsAnastomotic LeakHypoxia

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 22, 2021

Study Start

November 1, 2020

Primary Completion

March 30, 2021

Study Completion

April 30, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

JP(1)