Health-Related Quality Of Life After Partial Gastrectomy for Gastric Cancer: Comparison of Reconstruction by Billroth II or Roux-en-Y. A Randomized, Comparative, Multicentric, Single-blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- HRQol with 3 targeted dimensions
研究概览
简要总结
The treatment of a local distal gastric cancer remains surgical before or after chemotherapy. Partial gastrectomy is recommended for distal location cancer The recommendations for restoring continuity are less evident. There are two main techniques: the Roux-En-Y (REY) requiring 2 anastomoses (gastro-jejunostomy and entero-enterostomy) and the Billroth 2 (B2) with a single anastomosis (gastro-jejunostomy). The choice remains matter of debate.
There was no difference on the global health status score from the QLQ-C30 questionnaire. However, the health-related quality of life (HRQoL) was significantly improved only in the REY group between pre- and post-gastrectomy. A significant difference for endoscopic gastritis in favor of the REY group was reported.
The purpose of this study is to determine which surgical technique improve the health related quality of life after distal gastrectomy.
详细描述
The realization of REY suggests an improvement of the HRQoL after distal gastric resection in comparison to the B2 anastomosis justifying the need of a RCT on the topic. Moreover, the REY could improve the gastro-intestinal symptoms and gastritis. The investigators hypothesize that the REY intervention after distal gastrectomy will improve HRQoL for 3 targeted dimensions of the EORTC QLQ-OG25 questionnaire (eating, reflux, pain and discomfort) in patients with gastric cancer.
All patients with a distal gastric cancer treated in curative intent by surgery with distal gastrectomy should be included. The choice of this population belongs in the fact that no reconstruction according billroth2 are performed for other gastric cancer requiring a total gastrectomy. Therefore, all patients treated by total gastrectomy need to be excluded. Secondly, the increase in survival of this population in the past decade araising to 75% at 5 years allows investigators to question the quality of life after surgery.
The anastomosis is realized with the proximal jejunum without entero-enterostomy in the first 70 cm after the angle of Treitz. The gastrojejunostomy could be ante-colic or trans-mesocolic. The anastomosis could be performed according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).
The length of jejunum of the Y section needs to be at least 60 cm. The Roux-en-Y anastomosis could be antecolic or transmesocolic. The anastomosis could be realized according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).
The choice between these two techniques will not add an increased risk to the patient since they are both recommended by national guidelines, they are both performed as standard care and there is no difference in Quality of Life at long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years, men or women
- •Patients treated for adenocarcinoma of the antrum accessible to a surgical treatment with curative intent by distal gastrectomy. If patients present a linitis plastica, negative proximal and distal margin will be evaluated at the beginning of the surgery before randomization in order to perform a R0 resection
- •Patients with a registration in a national health care system (CMU included) (registered or being a beneficiary of such a scheme)
- •Patients able to understand and fulfill questionnaires in French language
- •Patients having given their written informed consent prior to participation in the study
排除标准
- •Patients with preoperative peritoneal metastasis or distant metastasis
- •Palliative surgery patients
- •Patients under tutorship or curatorship and protected adults
- •Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)
- •Patients deprived of liberty by judicial or administrative decision and patients under psychiatric care (admitted to a health or social care establishment)
- •Patients unable to give their consent
- •Pregnant or breastfeeding women
- •Women of childbearing age without effective contraception
研究组 & 干预措施
Billroth 2 (B2)
干预措施: Billroth 2 (B2) (Procedure)
Roux-En-Y (REY)
干预措施: Roux-En-Y (REY) (Procedure)
结局指标
主要结局
HRQol with 3 targeted dimensions
时间窗: One year post-surgery
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, OesophagoGastric 25 (EORTC QLQ-OG25) at 1 year post surgery with 3 targeted dimensions : eating, reflux, pain and discomfort. Health-related Quality of life (HRQoL) will be considered as being improved in one arm if at least one of the 3 targeted dimensions is significantly improved without a significantly deterioration for the other 2 targeted dimensions : * Eating restrictions : \[0-100\]. * Reflux : \[0-100\]. * Pain and discomfort : \[0-100\]. If high scores = more problems.
次要结局
- The long-term HRQoL after surgery for gastric cancer at 2 years(2 years post-surgery)
- Longitudinal changes of each HRQoL dimension(The long-term HRQoL (EORTC QLQ-OG25 questionnaire) after surgery for gastric cancer at 2 years)
- Other EORTC QLQ-OG25 dimensions(Baseline, 3 months, 6 months, 1 year and 2 years post-surgery)
- Other HRQoL dimensions(Baseline, 3 months, 6 months, 1 year and 2 years post-surgery)
- Longitudinal changes of each HRQoL dimension(et The long-term HRQoL (EORTC QLQ-C30 questionnaire) after surgery for gastric cancer at 2 years)
- The post-operative morbidity rates at 90 days(90 days post-surgery)
- The post-operative morbidity rates at 1 year(1 year post-surgery)
- The endoscopic biliary reflux rate and gastritis at 1 year post surgery(1 year post-surgery)
- The rate of proton pump inhibitor (PPI) use at 3 months, 6 months, 1 year and 2 years post-surgery(3 months, 6 months, 1 year and 2 years post-surgery)
- The survival at 1 year(1 year post-surgery)
- The survival at 2 years(2 years post-surgery)