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Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

Transhiatal/Transabdominal Approach Compare With Thoracoabdominal Approach for Siewert II Adenocarcinoma of Esophagogastric Junction

Recruiting
18-75 years
All
Phase N/A

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Overview

To compare transhiatal / transabdominal approach with thoracoabdominal approach for Siewert II adenocarcinoma of esophagogastric junction

Description

Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert â…¡ adenocarcinoma of esophagogastric junction.

Methods: A prospective, multi-center, randomized, controlled study will be performed. Patients who meet the eligibility criteria will be registered in the study and undergo radical surgery via transhiatal/transabdominal or thoracoabdominal approach. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

The primary endpoints :3-year disease-free survival. The secondary endpoints:(1) Surgery and oncology indicators ;(2) The incidences of postoperative complications and mortality.

Eligibility

Inclusion Criteria:

  • 1.18~75 years old
  • 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(Siewertâ…¡) .
  • 3.Histological diagnosis of adenocarcinoma
  • 4. American Society of Anesthesiologists(ASA) physical status class is less than or equal to 3
  • 5.Informed consent of patients

Exclusion Criteria:

  • 1.Patients with distant metastasis (M1) or invasion of surrounding organs
  • 2.History of esophagectomy and gastrectomy (including endoscopic mucosal resection/endoscopic submucosal dissection for gastric cancer and esophageal cancer)
  • 3.History of other malignant tumors within 5 years
  • 4.The researcher believes that the patient is not suitable to participate in the clinical trial
  • 5.Patients who persist in withdrawing from clinical trials

Study details
    Adenocarcinoma of Esophagogastric Junction

NCT04910789

Chinese PLA General Hospital

27 January 2024

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