Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Apr 29, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on comparing two different surgical methods for treating Siewert Type II adenocarcinoma, a type of cancer located at the junction of the esophagus and stomach. The trial aims to understand which method—endoscopic Ivor-Lewis surgery or laparoscopic extended abdominal gastrectomy—is safer and more effective for patients who can have their tumors surgically removed.

To be eligible for the trial, participants should be between 18 and 75 years old and have been diagnosed with Siewert Type II adenocarcinoma that can be surgically removed. They must also be in generally good health, with proper functioning of their blood, liver, and kidney systems. Participants will undergo one of the two surgical procedures and will be closely monitored for their recovery and outcomes. It's important to note that certain patients, such as those with significant heart or lung problems or other serious health conditions, will not be eligible to ensure everyone's safety during the trial.

Gender

ALL

Eligibility 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 \&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)