The availability study of tissue oxygenation monitor in gastric tube reconstruction

JRCT ID: jRCTs042210003

Registered date:05/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 19/04/2021
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Measure the tissue oxygen saturation of the anastomosis in gastric tube before and after raising it up to cervical area.

Outcome(s)

• Primary Outcome: The rate of tissue oxygen saturation over 45% as the index of enough blood stream in the anastomosis of gastric tube raised up to cervical region.

Secondary Outcome

The rate of anastomotic leakage
The percent of change of tissue oxygen saturation between before and after raising gastric tube up to the cervical region
Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who are planned to undertake radical esophagectomy with esophageal cancer or esophago-gastric junctional cancer
(2) Right open or thoracoscopic or robot assisted esophagectomy.Open or laparoscopic gastric tube reconstruction
Cervical anastomosis
(3) Any histologic type of esophageal cancer or esophago-gastric junctional cancer
(4) Written informed consent
(5) Over 20 years of age
(6) ECOG Performance status is 0 or 1

Exclude criteria

(1) Not making a use of gastric tube reconstruction.
(2) uncontrollable diabetes mellitus
(3) unstable angina or myocardial infarction within 6 months
(4) uncontrollable hypertension
(5) continuous intake of steroid or immunosuppressant
(6) SPO2 below 93%
(7) severe arteriosclerosis obliterans
(8) other cancer that needs combined operation
(9) Unappropriate for this study in the doctor`s judgement

Related Information

• Primary Sponsor: Tsubosa Yasuhiro