Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 654
- 试验地点
- 31
- 主要终点
- Overall survival
研究概览
简要总结
Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits.
The omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery.
There is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival.
OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.
详细描述
Primary objective:
The primary study objective is evaluate whether preservation of the omentum distal to the gastroepiploic vessels in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.
Secondary objectives:
Comparing the two study arms with regard to:
- Operating time
- Intraoperative blood loss
- Intraoperative complications
- Postoperative complications, defined according to the Clavien-Dindo classification25 and comprehensive complication index (CCI)
- Distribution of lymph node metastases
- R0-resection rate
- Rate of malignant cells in cytology
- Molecular sub classification of gastric cancer
- ICG fluorescent enhancement of omentum in omentum preservation group (in centers that have ICG fluorescence available)
- Protocol compliance to allocated treatment
- Hospital stay, defined as time interval between date of surgery and date of hospital discharge
- Readmission rate within 30-days after surgery
- Reintervention rate within 30-days after surgery
- Reoperation rate within three years after surgery
- Quality of life at baseline, 3, 6, 9, 12 and 24 months, the following questionnaires will be used: EQ-5D-5L, QLQ-C30, QLQ-OG25, CIPN, Happiness, HADS and work productivity
- 3- & 5-year disease-free survival, defined as the period of time from operation to locoregional recurrence, peritoneal recurrence, distant metastases, second gastric cancer or death from any cause. Patients alive and free of all these events will be censored at the last follow-up.
- 5-year overall survival, defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up.
- Cost-effectiveness
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
- None
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
- •Primary resectable gastric adenocarcinoma, clinical stage T1-4aN0-3M0
- •ASA 1-3 (able to undergo surgery)
- •Scheduled for open or minimally invasive (sub)total gastrectomy with modified D2-lymphadenectomy, with or without perioperative chemotherapy
- •Age above 18
- •Able to complete questionnaires in Dutch, English or Italian
- •Written informed consent
- •Esophageal invasion < 2 cm defined from the upper margin of the gastric rugae as determined by endoscopy
排除标准
- •Gastric cancer clinically staged as T1N0
- •Locally advanced gastric cancer requiring multi-visceral resection
- •Pregnancy
- •Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than three years before diagnosis of gastric cancer, or with a life expectancy of more than five years from date of inclusion
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator
- •Previous gastric or omental surgery, with the exclusion of a gastric perforation Indication for thoracotomy/thoracoscopy
结局指标
主要结局
Overall survival
时间窗: 3 years after surgery
Overall survival is defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up
次要结局
- Postoperative complications(Within 30-days after surgery)
- Quality of life assessment(At baseline, 3, 6, 9, 12 and 24 months)
- Reoperation rate(Within 3 years after surgery)
- Reintervention rate(Within 30-days after surgery)
- Distribution of lymph node metastases(Pathology report 1/2 weeks after surgery)
- Rate of malignant cells in cytology(Pathology report 1/2 weeks after surgery)
- Molecular sub classification of gastric cancer(Pathology report 1/2 weeks after surgery)
- Protocol compliance to allocated treatment(Up to 5 years)
- Readmission rate(Within 30-days after surgery)
- 5-year overall survival(5 years after surgery)
- Intraoperative blood loss(Intraoperative)
- R0-resection rate(Pathology report 1/2 weeks after surgery)
- Hospital stay(Up to 5 year)
- Operative time(Intraoperative)
- 3- & 5-year disease-free survival(After 3 years and 5 years post-operative)
- Cost-effectiveness(Up to 3 years post-operative)
研究者
Suzanne S. Gisbertz
Principal Investigator
Amsterdam UMC, location VUmc