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Clinical Trials in China / NCT05356520
Recruiting Not applicable

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

NCT05356520 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital of Digestive Diseases
Phase
Not applicable
Started
2022-05-01
Last updated
2024-11-08

Condition(s) studied

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Investigational drug(s) / intervention(s)

Endoscopy Ivor-lewisLaparoscopic transabdominal enlarged gastrectomy

Endoscopy Ivor-lewis: Endoscopy Ivor-lewis

Laparoscopic transabdominal enlarged gastrectomy: Laparoscopic transabdominal enlarged gastrectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Li Xi'an Shaanxi Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05356520 on ClinicalTrials.gov ↗ ← All trials in China