Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy
关键词
抽象
描述
Standard Operating Procedure (SOP)
1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Randomization: Intraoperative evaluation found that R0, proximal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
3. Surgical procedures: The surgical treatments is adopted the proximal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Group A take the gastric tube anastomosis and Group B take the double-track anastomosis (the reconstruction method is described in the intervention section of study groups). The two study will take the similar surgical procedures except for the digestive track reconstruction.
4. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
5. Follow-up: The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the European Organization for Research and Treatment of Cancer (EORCT) QLQ-C30 and STO-22 questionnaires. At the postoperative 12 moths, the upper gastrointestinal scope is needed to examine the reflux esophagitis and the remnant gastritis according to Los Angeles Classification of esophagitis. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months).
日期
| 最后验证: | 11/30/2017 |
| 首次提交: | 09/28/2014 |
| 提交的预估入学人数: | 11/05/2014 |
| 首次发布: | 11/10/2014 |
| 上次提交的更新: | 12/06/2017 |
| 最近更新发布: | 12/10/2017 |
| 实际学习开始日期: | 11/30/2014 |
| 预计主要完成日期: | 11/30/2017 |
| 预计完成日期: | 11/30/2017 |
状况或疾病
干预/治疗
Procedure: Group A (Gastric tube anastomosis)
Procedure: Group B (double-track anastomosis)
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Group B (double-track anastomosis) Patients in the Group B will received the double-track anastomosis with proximal gastrectomy. | Procedure: Group B (double-track anastomosis) Double-track anastomosis group: First, cut off the jejunum about 15-20 cm away from the Treitz ligament; Second, Roux-en-Y esophagojejunostomy (E-J stomy, first anastomosis) was perform by 25mm circular stapler device; Third, from 30-40cm to the E-J stomy, perform the side-to-side gastrojejunostomy (G-J stomy, second anastomosis). Forth, from 25-30cm to the G-J stomy, perform the jejunojejunostomy (J-J stomy, third anastomosis).
(Reference: Ahn SH, Jung do H, Son SY, Lee CM, Park do J, Kim HH. Laparoscopic double-tract proximal gastrectomy for proximal early gastric cancer. Gastric Cancer. 2014;17(3):562-70.) |
| Other: Group A (Gastric tube anastomosis) Patients in the Group A (Gastric tube anastomosis) will take the gastric tube anastomosis with proximal gastrectomy. | Procedure: Group A (Gastric tube anastomosis) In the gastric tube group, the lesser curvature of the gastric remnant approximately 3 cm proximal to the pylorus was removed first by a linear stapling device. An approximately 5-cm-wide tubular stomach was then constructed with preserved right gastric vessels. The length of the tube was consistent with the greater curvature of the residual stomach. The reconstructed gastric tube was lastly anastomosed with the proximal esophageal end.
(Reference: Chen XF, Zhang B, Chen ZX, Hu JK, Dai B, Wang F, Yang HX, Chen JP. Gastric tube reconstruction reduces postoperative gastroesophageal reflux in adenocarcinoma of esophagogastric junction. Dig Dis Sci. 2012;57(3):738-745.) |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma, and predictively feasible of proximal gastrectomy ; 2. Predictively resectable diseases, early gastric cancer, of preoperative staging JGCA 14th Edition cT1N0M0-T2N0M0; 3. Age：≤75 years, or ≥18 years; 4. Without serious disease and malignance disease; 5. Patients without previous history of upper abdominal surgery; 6. WHO performance score ≤2, ASA score ≤3; 7. No limit to sexual and race; 8. informed consent required. Exclusion Criteria: 1. With the history of the malignance disease; 2. 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. 3. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation; 4. Severity mental diseases; 5. After signature the Clinical trial agreement, patients and their agent will quit the trial; 6. 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 7. After signature the Clinical trial agreement, patients and their agent will quit the trial. |
结果
主要结果指标
1. postoperative mortality and morbidity [postoperative period (30 days)]
次要成果指标
1. Intraoperative mortality and morbidity [Intraoperative]
2. postoperative quality of life [Postoperative period (at least one year)]
3. remnant gastritis [postoperative period (one year)]
4. reflux esophagitis [Postoperative period (one year)]
