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

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

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

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of Esophagogastric Junction
• Intervention / Treatment: Procedure: thoracoabdominal approach; Procedure: transhiatal/transabdominal approach

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 Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinxin Wang, Dr; Phone Number: +8613811858199; Email: 301wxx@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Xinxin Wang, Dr.; Phone Number: +8613811858199; Email: 301wxx@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracoabdominal approach; Radical surgery should be finished via Thoracoabdominal approach.	Procedure: thoracoabdominal approach; Radical surgery should be finished via thoracoabdominal approach
Active Comparator: Transhiatal/transabdominal approach; Radical surgery should be finished via transhiatal/transabdominal approach.	Procedure: transhiatal/transabdominal approach; Radical surgery should be finished via transhiatal/transabdominal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of R0-resection	The proportion of patients undergoing radical resection in all surgical patients	About 10 days after surgery
The number of lymph node dissections and the positive	The number of lymph node dissections and the positive	About 10 days after surgery
The duration of postoperative hospitalization	Time from end of surgery to discharge	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 (%).	Within 30 days after surgery
The incidence of perioperative mortality	The incidence of death due to the surgery	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Publications and helpful links

General Publications

• Song Q, Li X, Wu D, Li S, Xie T, Lu Y, Zhang L, Xu Z, Liu L, Guo X, Wang X. The abdominal-transhiatal surgical approach versus the thoracoabdominal surgical approach in Siewert type II adenocarcinoma of the esophagogastric junction: protocol for a multicenter prospective, open, parallel, and randomized controlled trial. BMC Cancer. 2022 Mar 24;22(1):318. doi: 10.1186/s12885-022-09375-w.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 29, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms
• Other Study ID Numbers: S2AEG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No