Robot-assisted transmediastinoscopic esophagectomy for esophageal and esophagogastric junction cancer

JRCT ID: jRCT1030240620

Registered date:20/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer, esophagogastric junction cancer
• Date of first enrollment: 20/01/2025
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Performing the abdominal part of mediastinoscopic esophagectomy robotically, up to transhiatal middle mediastinal dissection

Outcome(s)

• Primary Outcome: Incidence of postoperative recurrent laryngeal nerve palsy
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 84age old
• Gender: Both

Include 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.

Exclude 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%)

Related Information

• Primary Sponsor: Ogawa Koichi
• Source(s) of Monetary Support: Department of gastrointestinal and hepatobilliary pancreatic surgery, University of Tsukuba