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

Chinese PLA General Hospital312 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Adenocarcinoma of Esophagogastric Junction

Interventions

transhiatal/transabdominal approachPROCEDURE

Radical surgery should be finished via transhiatal/transabdominal approach

thoracoabdominal approachPROCEDURE

Radical surgery should be finished via thoracoabdominal approach

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

3-year disease-free survival

Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up

Time frame: 3 years after surgery

Secondary Outcomes

The rate of R0-resection

The proportion of patients undergoing radical resection in all surgical patients

Time frame: About 10 days after surgery

The number of lymph node dissections and the positive

Time frame: About 10 days after surgery

The duration of postoperative hospitalization

Time from end of surgery to discharge

Time frame: Within 6 months after surgery

The incidences of early postoperative complications

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 (%).

Time frame: Within 30 days after surgery

The incidence of perioperative mortality

The incidence of death due to the surgery

Time frame: Within 30 days after surgery

Central Contacts

Xinxin Wang, Dr

CONTACT

+8613811858199 301wxx@sina.com

Data from ClinicalTrials.gov

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