A Multicenter Randomized Controlled Study Comparing Endoscopic Ivor-Lewis Versus Laparoscopic Transabdominal Extended Gastrectomy for Siewert II Esophagogastric Junction Adenocarcinoma
Led by Xijing Hospital of Digestive Diseases · Updated on 2024-11-08
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156 weeks
Total Duration
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Xijing Hospital of Digestive Diseases
Lead Sponsor
T
Tang-Du Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the best surgical method for treating Siewert type II adenocarcinoma of the esophagogastric junction, a condition where tumors occur at the junction between the esophagus and stomach. There is controversy about whether to use a right chest (endoscopic Ivor-Lewis) or left chest (laparoscopic extended abdominal gastrectomy) approach. This trial aims to compare the safety, feasibility, and clinical effectiveness of these two surgical techniques to improve patient outcomes.
The study compares two procedures: the endoscopic Ivor-Lewis operation and the laparoscopic transabdominal extended gastrectomy, both used to remove tumors at the esophagogastric junction. Participants are randomly assigned to one of these two surgical methods. The trial is multicenter and randomized, designed to provide new clinical data to help standardize treatment for this specific type of tumor.
During the study, participants will be monitored for disease-free survival over three years, with additional follow-up for overall survival up to five years. Researchers will also track postoperative complications, mortality within one month, and tumor recurrence over three years. Assessments include clinical evaluations and imaging before surgery and careful postoperative monitoring to measure treatment outcomes and safety. The total participation duration spans several years to capture these important results.
CONDITIONS
Brief Title
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
Histologically confirmed esophagogastric junction type II adenocarcinoma
Tumor removable by laparoscopy through gastrodiaphragmatic esophageal hiatus or endoscopic Ivor-Lewis operation
Pretreatment stage CT1-4A, N0-3, M0
For cT4a stage, tumor must be clearly resectable before randomization
Completed 4 cycles of FLOT chemotherapy before surgery for locally advanced tumors (CT3-T4 or N+)
Age 18 to 75 years
ECOG performance status 0 to 2
ASA score less than 4
Good bone marrow function (leukocyte > 1x10^9/L; hemoglobin > 9 g/dl; platelet > 100x10^9/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 patient and family
You will not qualify if you...
Esophagogastric junction type I or III adenocarcinoma
Tumor spreads more than 5 cm above the esophagogastric junction
Significant active heart disease or recent myocardial infarction within 12 months with ejection fraction < 50%
Significant lung disease with forced expiratory volume in 1 second (FEV1) < 1.5 l/s
Pregnant or nursing women
Stump gastric cancer
Borrmann Type 4 stomach cancer (leather stomach)
Other simultaneous or previous malignant tumors except certain in situ or focal carcinomas
History of right thoracotomy or right pleural adhesion
Cirrhosis or indocyanine green test ≥ 15% indicating chronic liver disease
Uncontrolled seizures, central nervous system diseases, or mental disorders
History of upper abdominal surgery except laparoscopic cholecystectomy
Uncorrectable coagulation disorders
Failure of heart, lung, liver, brain, kidney, or other important organs
Metabolic diseases such as diabetes
Immunosuppressive therapy including organ transplantation or SLE
Serious uncontrolled recurrent infections or concomitant diseases
Diseases requiring simultaneous surgery
Emergency surgery required due to tumor complications such as bleeding, perforation, or obstruction
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Surgical procedure with immediate hospitalization period
Participants undergo either endoscopic Ivor-Lewis operation or laparoscopic transabdominal enlarged gastrectomy for Siewert type II adenocarcinoma of the esophagogastric junction.
1 hospital stay for surgery and immediate recovery
Post-operative Follow-up
Duration - Up to 5 years including early postoperative period and long-term monitoring
Participants are monitored for postoperative complications, recovery, and tumor recurrence over the following months and years.
Approximately monthly visits for the first month, then periodic follow-up visits over several years
Comparison of thoracoabdominal versus abdominal-transhiatal surgical approaches in Siewert type II adenocarcinoma at the esophagogastric junction: Protocol for a prospective multicenter randomized controlled trial.