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

Adenocarcinoma of Esophagogastric Junction Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910789
• Other study ID #: S2AEG
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2021
• Source: Chinese PLA General Hospital
• Contact: Xinxin Wang, Dr
• Phone: +8613811858199
• Email: 301wxx[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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(Siewert?) .
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagogastric Junction

Intervention

Procedure:
• transhiatal/transabdominal approach
Radical surgery should be finished via transhiatal/transabdominal approach
• thoracoabdominal approach
Radical surgery should be finished via thoracoabdominal approach

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival	Proportion of patients without tumor recurrence from surgery to the end of the 3-year follow-up	3 years after surgery
Secondary	The rate of R0-resection	The proportion of patients undergoing radical resection in all surgical patients	About 10 days after surgery
Secondary	The number of lymph node dissections and the positive	The number of lymph node dissections and the positive	About 10 days after surgery
Secondary	The duration of postoperative hospitalization	Time from end of surgery to discharge	Within 6 months after surgery
Secondary	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 (%).	Within 30 days after surgery
Secondary	The incidence of perioperative mortality	The incidence of death due to the surgery	Within 30 days after surgery