Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Proximal Gastrectomy
  Resection of the upper third to one-half of the stomach and the distal portion of the esophagus with different types of digestive system reconstruction

Первичные конечные точки

• The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment [Срок оценки: within 90 days after operation]
• Overall survival [Срок оценки: 1 year after operation]
• Frequency of local recurrence [Срок оценки: 1 year after operation]
• Frequency of tumor progression [Срок оценки: 1 year after operation]

Вторичные конечные точки (7)

• Incidence of development and the severity of reflux esophagitis [Срок оценки: 6 and 12 months after surgery]
• Incidence of development of esophageal anastomotic stricture [Срок оценки: 6 and 12 months after surgery]
• Incidence and severity of dumping syndrome [Срок оценки: 6 and 12 months after surgery]
• Pressure of the esophageal anastomosis [Срок оценки: 6 and 12 months after surgery]
• The level of body weight reduction [Срок оценки: 6 and 12 months after surgery]
• The level of hemoglobin [Срок оценки: 6 and 12 months after surgery]
• Food passage rate through the esophagus and the stump of the stomach [Срок оценки: 6 and 12 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Россия · 1 центр

• P.Herzen Moscow Oncological Research Institute — Moscow

Идентификаторы

NCT: NCT07441785 · 110-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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