Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy (NCT02110628) | Clinical Trial Compass
UnknownPhase 3
Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy
China588 participantsStarted 2014-08
Plain-language summary
Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of total gastrectomy;
✓. Predictively resectable diseases, either early or locally advanced gastric cancer, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT1N0M0-T4aN3M0, I-IIIb, except T4b;
✓. Age: 18-75 years;
✓. Without serious disease;
✓. WHO performance score \< 2;
✓. No limit to sexual and race;
✓. Informed consent required
Exclusion criteria
✕. Primary lesion cannot be resected in the pattern of transabdominal total gastrectomy, but for Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
✕. Patients with other gastric malignant diseases, such as lymphoma and stromal tumors etc.
. Patients suffering from malignant diseases before the study;
✕. Patients with other severe comorbidities and cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe chronic obstructive pulmonary disease (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.
✕. Performed emergency operation due to bleeding or perforation;
✕. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
✕. Not the radical surgery, but with tumor residual (R1 or R2).