A randomized phase II study of robot-assisted thoracoscopic versus thoracoscopic esophagectomy for patients with curative surgery for thoracic esophageal cancer

A randomized phase II study of robot-assisted thoracoscopic versus thoracoscopic esophagectomy for patients with curative surgery for thoracic esophageal cancer - RATE for TEC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035781

Enrollment

Registered

2019-02-15

Start date

2019-03-01

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

Thoracic esophageal cancer

Interventions

Thoracoscopic esophagectomy for thoracic esophageal cancer Robot assisted thoracoscopic esophagectomy for thoracic esophageal cancer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) Clinical stage I,II,III(excluding T4), UICC-TNM 8th, 4) Surgery approached from the neck, chest and abdomen (R0 resection) with D2 dissection followed by gastric conduit reconstruction, 5) >20 and <80 y.o., 6) ECOG-PS 0 or 1, 7) BMI >17 and <30, 8) No history of surgery for esophageal cancer, 9 ) No history of chemotherapy or radiotherapy, 10) No history of right thoracotomy or left lung lobectomy, 11) FEV1.0 >1.0L, 12) a) WBC >2000 and <10000/mm3, b) PLT >50000/mm3, c) Hb >10.0 g/dl, d) AST <100 IU/L, ALT <100IU/L, e) T-Bil <2.0 g/dl, f) Cre <1.5mg/dl, g) SpO2 >95%, 13) Written consent

Exclusion criteria

Exclusion criteria: 1) Excision of other organs excluding gall bladder, 2) Active double cancer, 3) Pregnancy or breast-feeding, 4) Psychosis or mental symptoms, 5) Systemic administration of steroids, 6) History of myocardial infarction or unstable angina, 7) Poorly controlled hypertension, 8) Poorly controlled diabetes, 9) Respiratory disease requiring sustained oxygen therapy.

Design outcomes

Primary

Measure	Time frame
Incidence of Grade I or more postoperative recurrent nerve paralysis in Clavien-Dindo classification	—

Secondary

Measure	Time frame
1) Grade II and more total complications in Clavien-Dindo classification, 2) Operation time, 3) Blood loss, 4) Number of dissected mediastinum lymph node, 5) Change of surgical method, 6) Intraoperative adverse event, 7) Postoperative hospital stay , 8) QOL score (EORTC QLQ-C30, EORTC QLQ-OES18, EQ-5D-5L), 9) Operation related death, 10) Recurrent free survival	—

Countries

Japan

Contacts

Public ContactHiroshi Okamoto

Tohoku University Hospital Department of Surgery

hi-ok-0531@med.tohoku.ac.jp022-717-7214

Outcome results

None listed

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