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

Not Applicable

Recruiting

• Conditions: Adenocarcinoma of Esophagogastric Junction
• Interventions: Procedure: thoracoabdominal approach; Procedure: transhiatal/transabdominal approach

• Registration Number: NCT04910789
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-12-11
• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-29
• Last Update Submitted: 2021-05-29
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracoabdominal approach	thoracoabdominal approach	Radical surgery should be finished via Thoracoabdominal approach.
Transhiatal/transabdominal approach	transhiatal/transabdominal approach	Radical surgery should be finished via transhiatal/transabdominal approach.

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival	3 years after surgery	Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up

Secondary Outcome Measures

Name	Time	Method
The incidence of perioperative mortality	Within 30 days after surgery	The incidence of death due to the surgery
The rate of R0-resection	About 10 days after surgery	The proportion of patients undergoing radical resection in all surgical patients
The number of lymph node dissections and the positive	About 10 days after surgery	The number of lymph node dissections and the positive
The duration of postoperative hospitalization	Within 6 months after surgery	Time from end of surgery to discharge
The incidences of early postoperative complications	Within 30 days after surgery	The incidence of postoperative complications such as pneumonia, pleural effusion, anastomotic stenosis, anastomotic leakage, duodenal stump fistula, pancreatic fistula, abdominal abscess, and deep vein thrombosis (%).

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China