Comparing surgical methods for Siewert Type II adenocarcinoma at the esophagogastric junction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 \&lt; 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.