Surgical Outcomes and Long-Term Survival of Proximal Gastrectomy With Double-Tract Reconstruction at High-Volume Centers in Russia and China: A Two-Center Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Endoscopic reflux esophagitis
研究概览
简要总结
This two-center retrospective observational cohort study compares Chinese and Russian patients who underwent curative proximal gastrectomy with double-tract reconstruction for proximal gastric adenocarcinoma or Siewert type II/III adenocarcinoma of the esophagogastric junction. The study evaluates postoperative reflux, nutritional status, perioperative outcomes, complications, and long-term survival. Propensity score matching will be used to improve comparability between the two cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years.
- •Histologically confirmed gastric adenocarcinoma or Siewert type II/III adenocarcinoma of the esophagogastric junction.
- •Underwent proximal gastrectomy with double-tract reconstruction.
- •Surgery performed with curative intent.
- •At least one valid postoperative follow-up record containing reflux, nutritional, or complication information.
- •Clinical, pathological, operative, and follow-up data sufficiently complete for analysis, with less than 20 percent missingness in key variables.
排除标准
- •Previous gastric or esophageal surgery, except limited endoscopic treatment such as endoscopic mucosal resection.
- •Synchronous or metachronous malignancy, except cured non-melanoma skin cancer or cervical carcinoma in situ.
- •Complete absence of follow-up data.
- •Double-tract reconstruction not completed or changed to another reconstruction method.
- •Severe preoperative reflux disease, defined as GERD-Q score greater than 8 with a requirement for long-term medication.
研究组 & 干预措施
Chinese cohort
Patients treated at the First Affiliated Hospital of Nanjing Medical University who underwent proximal gastrectomy with double-tract reconstruction during the study source period.
干预措施: Proximal gastrectomy with double-tract reconstruction (Procedure)
Russian cohort
Patients treated at the Moscow Clinical Scientific Center named after A.S. Loginov who underwent proximal gastrectomy with double-tract reconstruction during the study source period.
干预措施: Proximal gastrectomy with double-tract reconstruction (Procedure)
结局指标
主要结局
Endoscopic reflux esophagitis
时间窗: 1 year after surgery
Presence and severity of reflux esophagitis assessed by endoscopy using the Los Angeles classification (grades A-D).
Clinically significant reflux symptoms
时间窗: 1 year after surgery
Reflux symptoms assessed using the GERD-Q questionnaire; a total score greater than 8 is considered clinically significant reflux.
Change in body mass index
时间窗: From preoperative baseline to 1 year after surgery
Change in body mass index, measured in kilograms per square meter.
Change in serum albumin
时间窗: From preoperative baseline to 1 year after surgery
Change in serum albumin concentration, measured in grams per liter.
Change in hemoglobin
时间窗: From preoperative baseline to 1 year after surgery
Change in hemoglobin concentration, measured in grams per liter.
次要结局
- Perioperative outcomes-Operative time(From surgery through hospital discharge, up to 6 months)
- Postoperative complications(Within 30 days after surgery)
- Overall survival(From the date of surgery until death or last follow-up, up to 12 years)
- Disease-free survival(From the date of surgery until recurrence, death, or last follow-up, up to 12 years)
- intraoperative blood loss(from surgery to discharge, up to 6 months)
- postoperative length of hospital stay(from surgery to discharge, up to 6 months.)
- conversion to open surgery(from surgery to discharge, up to 6 months)
研究者
Hao Xu
Dr.
The First Affiliated Hospital with Nanjing Medical University