NCT05356520 Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
| NCT ID | NCT05356520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Condition | Siewert Type II Adenocarcinoma of Esophagogastric Junction |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 212 participants in total. It began in 2022-05-01 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
xiaohua li, MD,PH.D
STUDY CHAIR
Xijing Hospital
Frequently Asked Questions
Who can join the NCT05356520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Siewert Type II Adenocarcinoma of Esophagogastric Junction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05356520 currently recruiting?
Yes, NCT05356520 is actively recruiting participants. Contact the research team at xjyylixiaohua@163.com for enrollment information.
Where is the NCT05356520 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT05356520 clinical trial?
NCT05356520 is sponsored by Xijing Hospital of Digestive Diseases. The principal investigator is xiaohua li, MD,PH.D at Xijing Hospital. The trial plans to enroll 212 participants.