A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic P… (NCT06347757) | Clinical Trial Compass
CompletedNot Applicable
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy
China180 participantsStarted 2020-01-01
Plain-language summary
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18-75 years old, male or female;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
✓. American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
✓. Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC;
✓. Patients without contraindications to surgery;
✓. Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;
Exclusion criteria
✕. Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
✕. Combined resection required due to other diseases (except cholecystectomy).
✕. History of cancer or concurrent cancer in other organs.
✕. Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.