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

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Adenocarcinoma of Esophagogastric Junction

Treatments: Procedure: thoracoabdominal approach; Procedure: transhiatal/transabdominal approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04910789

S2AEG

Details and patient eligibility

About

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

Full description

Objective: To compare the safety and clinical efficacy between transhiatal/transabdominal and thoracoabdominal approach for Siewert Ⅱ 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.

Enrollment: 312 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.18~75 years old
• 2.The tumor center located at the esophagogastric junction(EGJ) line from 1cm above to 2cm below(SiewertⅡ) .
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

Thoracoabdominal approach

Experimental group

Description:

Radical surgery should be finished via Thoracoabdominal approach.

Treatment:

Procedure: thoracoabdominal approach

Transhiatal/transabdominal approach

Active Comparator group

Description:

Radical surgery should be finished via transhiatal/transabdominal approach.

Treatment:

Procedure: transhiatal/transabdominal approach