Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively
研究概览
简要总结
Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is up to 62%, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional status than total gastrectomy.
Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach, which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016. It can reduce the occurrence of reflux oesophagitis. At present, the studies for double-flap technique in China and other countries are mostly retrospective studies, and there are short of large-scale prospective studies and evidence of evidence-based medicine.
The applicant has initiated a phase II, single center, single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer. To further validate the short and long-term outcomes of this procedure, a multicentre, open label, prospective, superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer. It include 216 patients with proximal early gastric cancer. The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The short and long-term oncological outcomes are also explored. This trial can provide high-grade evidence of evidence-based medicine for double-flap technique's clinical applications .
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years ≤ age ≤ 80 years
- •The primary gastric lesions were located in the proximal third of the stomach
- •histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
- •clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer(AJCC) staging system(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
- •scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or laparoscopic total gastrectomy with D1+/D2 lymphadenectomy , and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
- •The preoperative American Society of Anesthesiologists (ASA) physical status was I-III; The patient's cardiopulmonary function can tolerate laparoscopic surgery.
- •The patients have signed the informed consent form.
排除标准
- •history of upper abdominal surgery (except laparoscopic cholecystectomy);
- •the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
- •with other malignant diseases or have suffered from other malignant diseases within 5 years
- •require simultaneous surgery due to complicated with other diseases
- •women are pregnant or in lactation period
- •Suffering from serious mental illness
- •history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month
结局指标
主要结局
The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively
时间窗: 12 months postoperatively
During follow-up endoscopy 1 year after surgery, reflux esophagitis are graded according to the Los Angeles (LA) classification.
次要结局
- Changes in hemoglobin levels at Follow-up(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- Quality of Life after Surgery(Follow-up evaluations are performed 3, 6 and 12 months postoperatively)
- Changes in serum albumin levels at Follow-up(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- Late Postoperative Morbidity(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- 3-year overall survival rate(3 years)
- Proportion of participants need to rehospitalized after surgery(From surgery to discharge, up to 30 days)
- 5-year disease-free survival rate(5 years)
- Postoperative pain assessment(Day 1 postoperatively)
- Gastrointestinal Symptoms after Surgery(Follow-up evaluations are performed 3, 6 and 12 months postoperatively)
- Early Postoperative Morbidity(From surgery to discharge, up to 30 days)
- 3-year recurrence pattern(3 years)
- 5-year overall survival rate(5 years)
- 5-year recurrence pattern(5 years)
- body mass index postoperatively(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- Proportion of participants die after surgery(From surgery to discharge, up to 30 days)
- Changes in Vitamin B12 levels at Follow-up(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- Changes in total protein levels at Follow-up(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- Changes in prealbumin levels at Follow-up(Follow-up evaluations are performed 3, 6 and 12 months postoperatively.)
- 3-year disease-free survival rate(3 years)
- Quality of Life postoperatively(Follow-up evaluations are performed 3, 6 and 12 months postoperatively)
- Short-term Clinical Outcome After Surgery(From surgery to discharge, up to 30 days)
- Surgical Characteristics(24 hours postoperatively)
- Pathological Characteristics(1 week postoperatively)