Actively Recruiting
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
Led by Xijing Hospital of Digestive Diseases · Updated on 2024-11-08
212
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
Sponsors
X
Xijing Hospital of Digestive Diseases
Lead Sponsor
T
Tang-Du Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed EGJ type II adenocarcinoma
- 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, resectability must be confirmed before randomization
- Completion of all 4 cycles of FLOT chemotherapy before surgery for locally advanced tumors (CT3-T4 or N+)
- Age 18 to 75 years
- ECOG performance status 0-2
- ASA score less than 4
- Good bone marrow function (leukocytes >10 x 10^9/L; hemoglobin >9 g/dl; platelets >100 x 10^9/L)
- Adequate renal function (glomerular filtration rate >60 ml/min)
- Adequate liver function (total bilirubin <1.5 times normal, AST <2.5x ULN, ALT <3x ULN)
- Voluntary written informed consent signed by patients and family
You will not qualify if you...
- EGJ type I or III adenocarcinoma
- Tumor spreading more than 5 cm above the esophagogastric junction
- Active heart disease with left ventricular ejection fraction <50%
- Clinically significant lung diseases with FEV1 <1.5 l/s
- Pregnant or nursing women
- Stump gastric cancer
- Borrmann type 4 (Leather stomach)
- Other simultaneous or past malignant tumors except specific cervical or colorectal cancers
- History of right thoracotomy or right pleural adhesion
- Cirrhosis or chronic liver disease with indocyanine green test ≥15%
- Uncontrolled seizures, central nervous system diseases, or mental disorders
- History of upper abdominal surgery except laparoscopic cholecystectomy
- Uncorrectable coagulation dysfunction
- Organ failure affecting heart, lung, liver, brain, kidney
- Metabolic diseases like diabetes
- Immunosuppressive therapy such as organ transplant or lupus
- Uncontrolled recurrent infections or other serious diseases
- Other diseases requiring simultaneous surgery
- Conditions requiring emergency surgery due to tumor complications such as bleeding, perforation, or obstruction
AI-Screening
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Trial Site Locations
Total: 1 location
1
Li
Xi'an, Shaanxi, China, 710000
Actively Recruiting
Research Team
X
xiaohua Li, MD,PH.D
CONTACT
Z
zhenchang Mo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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