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A randomized phase II study of hand-assisted laparoscopic versus laparoscopic-assisted gastric mobilization for patients with curative surgery for thoracic esophageal cancer

A randomized phase II study of hand-assisted laparoscopic versus laparoscopic-assisted gastric mobilization for patients with curative surgery for thoracic esophageal cancer - A randomized study of laparoscopic gastric mobilization for thoracic esophageal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033669
Enrollment
90
Registered
2018-10-01
Start date
2018-10-01
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

Esophageal cancer

Interventions

Hand-assisted laparoscopic gastric mobilization for patients with curative surgery for thoracic esophageal cancer Laparoscopic-assisted gastric mobilization for patients with curative surgery for th

Sponsors

Tohoku University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) cT1-3, cN0-3 (exclude celiac lymph nodes) and cM0, 4) Surgery approached from the neck, chest and abdomen, 5) R0 resection with radical dissection, 6) Reconstruction by gastric tube, 7) >20 and <80 y.o., 8) ECOG-PS 0 or 1, 9) No history of surgery for esophageal cancer, 10) No history of chemotherapy or radiotherapy, 11) No history of surgery to upper abdomen, 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, 13) Written consent

Exclusion criteria

Exclusion criteria: 1) BMI <17.0 or >30.0, 2) Excision of other organs excluding gall bladder or spleen (for bleeding), 3) Active double cancer, 4) Pregnancy or breast-feeding, 5) Psychosis or mental symptoms, 6) Systemic administration of steroids, 7) History of myocardial infarction or unstable angina, 8) Poorly controlled hypertension, 9) Poorly controlled diabetes, 10) Respiratory disease requiring sustained oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Reconstructed gastric tube-related complication using Clavien-Dindo grading system

Secondary

MeasureTime frame
1) All complication using Clavien-Dindo grading system, 2) Operative time, 3) Estimated blood loss, 4) Conversion of operative procedure, 5) Adverse event of surgery, 6) QOL score, 7) Number of dissected abdominal lymph nodes, 8) Overall survival time.

Countries

Japan

Contacts

Public ContactHiroshi Okamoto

Tohoku University Hospital Department of Surgery

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

Outcome results

None listed

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