Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment
研究概览
简要总结
Proximal gastric and esophagogastric junction cancers comprise up to 40% of gastric malignancies. For localized disease, proximal gastrectomy is the main radical procedure, but reconstruction of GI tract often leads to significant functional issues.
Rising use of proximal resections and broader indications have increased attention to postoperative quality of life (QoL). Common reconstructions include direct esophagogastrostomy (various types), double-tract reconstruction, jejunal interposition, and newer anti-reflux anastomoses (e.g., double-flap, overlap, tunnel techniques).
Each method has unique pros and cons regarding reflux esophagitis, food passage, dumping syndrome, nutritional changes, and long-term QoL.
No consensus exists on the optimal technique, leading to variable practices and outcomes. Most research focuses on oncologic radicality and survival, while functional results and QoL remain understudied.
Systematic evaluation of functional outcomes across reconstruction types after proximal subtotal gastrectomy is needed in Russian Federation to improve QoL, advance research, and standardize treatment of proximal gastric and EGJ cancers.
详细描述
Proximal gastric and esophagogastric junction cancer account for up to 40% of all gastric malignancies. For localized disease, proximal gastrectomy remains the primary radical surgical procedure. However, roconstruction of gastrointestinal continuity after this procedure is associated with significant functional disturbances.
The increasing frequency of proximal resections and expanding indications have heightened focus on postoperative quality of life (QoL). Currently used reconstruction techniques include direct esophagogastrostomy (in various modifications), double-tract reconstruction, jejunal interposition, and emerging anti-reflux esophagogastric anastomoses (e.g., double-flap technique, single-overlap, tunnel reconstruction, etc).
Each method carries distinct advantages and disadvantages concerning reflux esophagitis, food passage, dumping syndrome, nutritional status alterations, and long-term QoL.
Despite this variety, no universal consensus exists regarding the optimal reconstruction technique, resulting in heterogeneous surgical practices and variable functional outcomes. Most studies prioritize oncologic radicality and overall survival, whereas functional results and QoL remain under-investigated.
To enhance patient QoL, advance research, and standardize treatment of proximal gastric and esophagogastric junction cancers in the Russian Federation, there is a clear need for systematic evaluation of functional outcomes across different reconstruction types following proximal subtotal gastrectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert I and II) cT1-3N0-2M0 undergoing proximal gastrectomy with curative intent - via open, laparoscopic or robotic approach between 01th January 2025 and 31th December 2026
排除标准
- •Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on a previous staging laparoscopy, or those with known synchronous other cancers.
- •Esophagogastric Junction Siewert I malignancy
- •Patients submitted to Emergency surgery or surgery without curative intent
- •Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy
- •Patients who have previously undergone surgery on the stomach or colon
研究组 & 干预措施
Patients with morbidity and mortality
Patients who suffered from any type of morbidity after surgery
干预措施: Proximal Gastrectomy (Procedure)
Patients without morbidity and mortality
Patients who did not suffered from any type of morbidity after surgery
干预措施: Proximal Gastrectomy (Procedure)
结局指标
主要结局
The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment
时间窗: within 90 days after operation
the types of complication is classified into as follows: esophageal anastomotic leak requiring surgical treatment, esophageal anastomotic leak not requiring surgical treatment, gastric stump necrosis, postoperative bleeding requiring surgical treatment, postoperative bleeding not requiring surgical treatment, postoperative ileum, postoperative pancreatic fistula type B, postoperative pancreatic fistula type C, duodenal stump leak / duodenal stump insufficiency, impaired evacuation from the gastric stump (more than 10 days after surgery), postoperative intestinal perforation or necrosis, persistent air leak through the pleural drain, wound dehiscence (evisceration, hernia), incarcerated diaphragmatic hernia, chylothorax or other types of lymph leakage, infectious complications of the postoperative wound, other complications requiring repeat intervention or another invasive procedure, other.
Overall survival
时间窗: 1 year after operation
Overall survival within 1 year after operation
Frequency of local recurrence
时间窗: 1 year after operation
Frequency of local recurrence within 1 year after operation
Frequency of tumor progression
时间窗: 1 year after operation
Frequency of tumor progression within 1 year after operation
The type of complications and the incidence of it
时间窗: within 90 days after operation
the types of complication is classified into as follows: esophageal anastomotic leak requiring surgical treatment, esophageal anastomotic leak not requiring surgical treatment, gastric stump necrosis, postoperative bleeding requiring surgical treatment, postoperative bleeding not requiring surgical treatment, postoperative ileum, postoperative pancreatic fistula type B, postoperative pancreatic fistula type C, duodenal stump leak / duodenal stump insufficiency, impaired evacuation from the gastric stump (more than 10 days after surgery), postoperative intestinal perforation or necrosis, persistent air leak through the pleural drain, wound dehiscence (evisceration, hernia), incarcerated diaphragmatic hernia, chylothorax or other types of lymph leakage, infectious complications of the postoperative wound, other complications requiring repeat intervention or another invasive procedure, other.
次要结局
- The level of hemoglobin(6 and 12 months after surgery)
- Food passage rate through the esophagus and the stump of the stomach(6 and 12 months after surgery)
- The level of body weight reduction(6 and 12 months after surgery)
- Incidence of development and the severity of reflux esophagitis(6 and 12 months after surgery)
- Incidence of development of esophageal anastomotic stricture(6 and 12 months after surgery)
- Incidence and severity of dumping syndrome(6 and 12 months after surgery)
- Pressure of the esophageal anastomosis(6 and 12 months after surgery)
研究者
Andrey Ryabov
Head of Department of Thoracoabdominal Oncology
P. Herzen Moscow Oncology Research Institute