Status:
RECRUITING
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Collaborating Sponsors:
Tang-Du Hospital
Henan Provincial People's Hospital
Conditions:
Siewert Type II Adenocarcinoma of Esophagogastric Junction
Eligibility:
All Genders
18-75 years
Phase:
NA
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 gr...
Detailed Description
At present, the main surgical approaches for the treatment of esophagogastric junction adenocarcinoma include single left thoracic incision, 2 right epigastric incisions, 2 left epigastric incisions, ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05356520
Start Date
May 1 2022
End Date
May 31 2028
Last Update
November 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Li
Xi'an, Shaanxi, China, 710000