Comparing two surgical approaches for a type of esophageal cancer
A Prospective, Multicenter, Randomized, Controlled Study Comparing Surgical Efficacy Between Transhiatal/Transabdominal and Thoracoabdominal Approach for Patients With Siewert II Adenocarcinoma of Esophagogastric Junction
This study is testing which of two different surgical methods is safer and more effective for treating a specific type of esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04910789 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and clinical efficacy of two surgical approaches—transhiatal/transabdominal and thoracoabdominal—for treating Siewert II adenocarcinoma of the esophagogastric junction. It is a prospective, multi-center, randomized, controlled study where eligible patients will undergo radical surgery using one of the two approaches. The study will collect and analyze data on preoperative, intraoperative, postoperative, and follow-up outcomes, focusing on disease-free survival and postoperative complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a histological diagnosis of adenocarcinoma located at the esophagogastric junction.
Not a fit: Patients with distant metastasis, prior esophagectomy or gastrectomy, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with adenocarcinoma of the esophagogastric junction.
How similar studies have performed: While similar surgical approaches have been explored, this specific comparison is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xinxin Wang, Dr
- Email: 301wxx@sina.com
- Phone: +8613811858199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.