Immediate and functional outcomes after different reconstructions following proximal stomach removal
Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer
This project will compare different ways of reconnecting the digestive tract after proximal gastrectomy to see which approach leads to better function and quality of life for people having surgery for cancers at the top of the stomach or the esophagogastric junction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | P. Herzen Moscow Oncology Research Institute Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07441785 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort of consecutive patients undergoing proximal gastrectomy with curative intent at a Moscow oncology center between January 1, 2025 and December 31, 2026, comparing commonly used reconstruction methods (direct esophagogastrostomy variants, double-tract, jejunal interposition, and anti-reflux anastomoses). Clinical and functional endpoints will include immediate postoperative morbidity and mortality, reflux esophagitis, food passage problems, dumping symptoms, nutritional changes, and patient-reported quality of life. Data will be collected prospectively after open, laparoscopic, or robotic procedures and analyzed to identify patterns of benefit and harm across techniques. The goal is to provide systematic, comparative functional outcome data to inform surgical decision-making and standardize care regionally.
Who should consider this trial
Good fit: Adults with clinically localized primary gastric cancer or Siewert type II–III esophagogastric junction cancer (cT1-3N0-2M0) scheduled for proximal gastrectomy with curative intent are eligible.
Not a fit: Patients with metastatic disease, Siewert type I tumors, emergency or non-curative surgery, prior stomach or colon surgery, synchronous other cancers, or those requiring additional procedures are excluded and unlikely to benefit from these comparisons.
Why it matters
Potential benefit: If successful, the findings could identify reconstruction methods that reduce reflux and nutritional problems and improve quality of life after proximal gastrectomy.
How similar studies have performed: Small series and single-center reports suggest some anti-reflux and double-tract techniques can reduce reflux and improve function, but there is no large, consistent evidence or consensus on the optimal approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Moscow
- P.Herzen Moscow Oncological Research Institute — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Vladimir Khomyakov, MD, PhD — P.Herzen Moscow Oncological Research Institute
- Study coordinator: Andrey Ryabov, MD, PhD
- Email: ryabovdoc@mail.ru
- Phone: +7 (495) 150-11-22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.