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Robot-assisted transmediastinoscopic esophagectomy for esophageal and esophagogastric junction cancer

Exploratory study to assess the safety of robot-assisted mediastinoscopic esophagectomy for cancer of the esophagus and esophagogastric junction. - Robot-assisted transmediastinoscopic esophagectomy for esophageal and esophagogastric junction cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240620
Enrollment
30
Registered
2025-01-20
Start date
2025-01-20
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, esophagogastric junction cancer Esophageal cancer, esophagogastric junction cancer

Interventions

Performing the abdominal part of mediastinoscopic esophagectomy robotically, up to transhiatal middle mediastinal dissection
D065287, D008481
Robotic-assisted, mediastinoscopic esophagectomy

Sponsors

Ogawa Koichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Cases of thoracic esophageal cancer and esophagogastric junction cancer of cStage I-III (12th edition of the Japanese Code of Cancer of the Esophagus) 2) Any histological type 3) Age between 20 and 84 years at the time of consent 4) Any gender and BMI 5) Cervical esophagogastric tube reconstruction is possible (stomach can be used as a reconstructive organ) 6) Patients with preserved function of major organs (spinal cord, heart, lungs, liver, etc.) who are deemed eligible for general anesthesia and surgery. 7) Patients who have been properly informed about the participation in this study, and who have given their free and voluntary written consent based on full understanding of the study.

Exclusion criteria

Exclusion criteria: 1) Cervical esophageal cancer cases 2) Cases in which robotic/laparoscopic surgery is not possible (e.g., severe intra-abdominal adhesions) 3) ECOG-PS2 or higher 4) Patients with poorly controlled diabetes mellitus 5) Severely impaired cardiac function (EF < 30%)

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative recurrent laryngeal nerve palsy

Secondary

MeasureTime frame
Perioperative complications other than recurrent nerve palsy (bleeding (intraoperative and postoperative), infection (intra-abdominal abscess, wound infection), suture failure, anastomotic stricture, pancreatic leakage and pancreatitis, delayed excretion of gastric contents, mastoidectomy, mastoabdomen, pneumothorax, hemothorax, pyothorax, tracheal necrosis, tracheal perforation, reconstructed organ necrosis, pulmonary embolism, other organ injury, cardiovascular, pulmonary and cerebral vascular infarction (e.g., pneumoperitoneum, intestinal obstruction, pneumonia, heart failure, liver failure, renal failure, abdominal wall scar hernia), open chest/open abdomen conversion rate, presence of blood transfusion, rate of surgery-related death, operation time, blood loss, number of lymph nodes dissected, postoperative hospital stay, rate of R0 resection

Contacts

Public ContactKoichi Ogawa

University of Tsukuba

k-ogawa@md.tsukuba.ac.jp+81-29-853-3221

Outcome results

None listed

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