The availability study of tissue oxygenation monitor in gastric tube reconstruction

Single arm phase II study about the availability of tissue oxygen saturation monitor in gastric tube reconstruction in esophagectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042210003

Enrollment

Registered

2021-04-05

Start date

2021-04-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Measure the tissue oxygen saturation of the anastomosis in gastric tube before and after raising it up to cervical area.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public ContactSyuhei Mayanagi

Shizuoka Cancer Center

s.mayanagi@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026