A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer

A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer - A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057302

Enrollment

120

Registered

2025-04-01

Start date

2025-04-01

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

surgical approach in abdominal part Group A: Hand-assisted laparoscopic surgery surgical approach in abdominal part Group B:Laparoscopic surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are planed to undergo thoracoscopic or robot assisted subtotal esophagectomy with retrosternal gastric tube reconstruction for thoracic esophageal cancer. 2) cT1-4a, N0-3, M0 or M1 (#104) according to UICC-TNM 8th edition. 5) Age 20 years or older. 6) Performance status (PS) is 0 or 1 according to ECOG criteria. 7) No history of treatment for esophageal cancer. Following history of treatment are eligible. Curative resection by EMR/ESD with pT1a-LPM (M2) or less, pT1a-MM (M3) and negative for vascular invasion. 8) No history of upper abdominal surgery or surgery involving intestinal resection. (Appendectomy and laparoscopic cholecystectomy are eligible). 9) Sufficient organ functions. i. WBC >= 3,000/mm3 ii. Platelet >= 100000 /mm3 iii. Hemoglobin >= 8.0 g/dL iv. T.Bil =< 2.0 mg/dL v. AST =< 100 U/L vi. ALT =< 100 U/L vii. Creatinine =< 2.0 mg/dL viii. SpO2 >= 95% 10) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. 5) Severe psychiatric disease. 6) Continuous systemic steroid or immune-suppressive drug therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Severe pulmonary fibrosis or emphysema. 9) Poorly controlled hypertension. 10) Poorly controlled diabetes mellitus in spite of continuous use of insulin.

Design outcomes

Primary

Measure	Time frame
incidence of postoperative pulmonary complications (Clavien-Dindo Grade II or higher)	—

Countries

Japan

Contacts

Public ContactTakuya Hamakawa

Osaka Rosai Hospital Surgery

hamakawa@osakah.johas.go.jp072-252-3561

Outcome results

None listed

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