Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy
Xijing Hospital of Digestive Diseases
212 participants
May 1, 2022
INTERVENTIONAL
Conditions
Summary
The incidence of esophagogastric junction has been increasing in recent years, and surgery is an important method for the treatment of adenoma at the esophagogastric junction. Currently, there is a great controversy about the surgical method of Siewert II, mainly choosing the right chest or the left chest for thoracic surgery. Therefore, it is of great significance to further study the surgical methods of Siewert II esophagogastric junction adenoma. Objective: To compare the safety, feasibility, and clinical efficacy of endoscopic Ivor-Lewis versus laparoscopic extended abdominal gastrectomy for Siewert type Ⅱadenocarcinoma at the resectable esophagogastric junction.
Eligibility
Inclusion Criteria10
- 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.
- 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 Criteria19
- 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)
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Interventions
Endoscopy Ivor-lewis
Laparoscopic transabdominal enlarged gastrectomy
Locations(1)
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NCT05356520