About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert II and III) cT1-3N0-2M0undergoing elective proximal gastrectomy curative intent - via open, laparoscopic or robotic approach
Trial design
Cohort
Prospective
Treatments tested in this trial
Proximal Gastrectomy
Procedure/SurgeryResection of the upper third to one-half of the stomach and the distal portion of the esophagus with different types of digestive system reconstruction
Treatment groups
Trial outcomes
Primary outcomes
The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment
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
Overall survival within 1 year after operation
Frequency of local recurrence
Frequency of local recurrence within 1 year after operation
Frequency of tumor progression
Frequency of tumor progression within 1 year after operation
Secondary outcomes
Incidence of development and the severity of reflux esophagitis
Incidence of development and the severity (degree of expression) of reflux esophagitis according to the Los Angeles classification in the postoperative period
Incidence of development of esophageal anastomotic stricture
Incidence of development of esophageal anastomotic stricture in the postoperative period.
Incidence and severity of dumping syndrome
Incidence and severity of dumping syndrome, along with quality of life assessment in the postoperative period according to the KOQUSS-40 questionnaire at 6 and 12 months postoperatively
Pressure of the esophageal anastomosis
Pressure of the esophageal anastomosis in the postoperative period according to esophageal manometry
Sponsors and contacts
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P. Herzen Moscow Oncology Research Institute
Lead sponsor
A.Loginov Moscow Clinical Scientific Center
Collaborator