Comparing surgical methods for Siewert Type II adenocarcinoma at the esophagogastric junction
A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
This study is testing two different surgical methods to see which one works better and is safer for people with Siewert Type II adenocarcinoma at the esophagogastric junction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05356520 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety, feasibility, and clinical efficacy of two surgical approaches—endoscopic Ivor-Lewis and laparoscopic extended abdominal gastrectomy—for treating Siewert Type II adenocarcinoma at the esophagogastric junction. The study addresses the ongoing debate regarding the optimal surgical method for this type of cancer, which has seen an increase in incidence. Patients will be randomized to receive one of the two surgical interventions, and outcomes such as postoperative complications and recovery will be assessed. The trial is significant due to the unique lymphatic spread patterns associated with Siewert Type II tumors, which may influence surgical success.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed Siewert Type II adenocarcinoma that is resectable.
Not a fit: Patients with Siewert Type I or III adenocarcinoma, or those with extensive tumor spread, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with Siewert Type II adenocarcinoma.
How similar studies have performed: Previous studies have explored various surgical approaches for esophagogastric junction adenocarcinoma, but this specific comparison of techniques for Siewert Type II is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed EGJ type II adenocarcinoma ··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation * Pretreatment stage CT1-4A, N0-3, M0 * For cT4a stage patients, their resectable properties must be clearly verified before randomization * For locally advanced tumors (CT3-T4 or N+), all 4 cycles of chemotherapy (FLOT) were completed before surgery. * 18 to 75 years old * ECOG score 0-2 * ASA \<4 * Good bone marrow function (leukocyte \> x 10 \^ 9 / l; Hemoglobin\> 9 g/dl. ·Platelet\>100×10\^9/ L), renal function (glomerular filtration rate \& GT; 60ml/min) and liver function (total bilirubin \< 1.5 times normal (ULN), aspartate aminotransferase (AST\< 2.5x ULN, Alanine aminotransferase (ALT)\<3 x ULN) * Patients and their family members voluntarily sign written informed consent Exclusion Criteria: * Histologically confirmed EGJ type I and III adenocarcinoma * Tumor spread over 5 cm proximal to EGJ * Clinically significant (active) heart disease (i.e. symptomatic coronary artery disease or myocardial infarction within the last 12 months) resulting in left ventricular ejection fraction\<50%(determined by echocardiography) * Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)\<1.5 l/s) * Pregnant women and nursing mothers * Stump gastric cancer * Borrmann Type 4 (Leather stomach) * Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma * Right thoracotomy or history of right pleural adhesion * Cirrhosis, or indocyanine green test ≥15% of chronic liver disease * No seizure control, central nervous system diseases or mental disorders * History of upper abdominal surgery (except laparoscopic cholecystectomy) * The patient has coagulation dysfunction and cannot be corrected * Patients with heart, lung, liver, brain, kidney and other important organ failure * Patients with metabolic diseases such as diabetes * Immunosuppressive therapy, such as organ transplantation, SLE, etc * Seriously out of control recurrent infections or other seriously out of control concomitant diseases * Other diseases requiring simultaneous surgery * Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)
Where this trial is running
Xi'an, Shaanxi
- Li — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: xianli he, MD,PH.D — Tang-Du Hospital
- Study coordinator: xiaohua Li, MD,PH.D
- Email: xjyylixiaohua@163.com
- Phone: +8613474299901
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.