Length of the Proximal Resection Margin for Siewert-II/Siewert-III Tumors (NCT02313688) | Clinical Trial Compass
UnknownNot Applicable
Length of the Proximal Resection Margin for Siewert-II/Siewert-III Tumors
China320 participantsStarted 2015-01
Plain-language summary
The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly during the past decades. By the Siewert classification, the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ. The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal approach gastrectomy has better survival outcomes compared with left thoracoabdominal approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still controversies. Previous study found that longer than 2cm proximal resection margin had better survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On the other sides, due to more advanced tumor stage of patients in China when compared with Japan and Korea. It is necessary to conduct a randomized control study to analyze the length of resection margin in advanced adenocarcinomas of esophagogastric junction.
Therefore, this study was aimed to include those Siewert II/III tumor patients in Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma (Siewert-II/Siewert-III), and predictively feasible of radical total gastrectomy;
✓. Without serious disease and malignance disease;
✓. WHO performance score ≤2, ASA score ≤3;
✓. No limit to sexual and race;
✓. Informed consent required.
Exclusion criteria
✕. Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
✕. Severity mental diseases;
✕. Primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
✕. After signature the Clinical trial agreement, patients and their agent will quit the trial.