Clinical Trial

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

Study acronym: PROXISTAT
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-04-23
notable Enrollment increased: 300 -> 400 participants 2026-04-23
notable Primary completion pushed: 2027-12-31 -> 2028-12-31 2026-04-23
minor Completion pushed: 2028-06-01 -> 2029-06-01 2026-04-23
Trial Details
NCT Number NCT07441785
Lead Sponsor P. Herzen Moscow Oncology Research Institute
Collaborators: A.Loginov Moscow Clinical Scientific Center
Conditions Gastric Cancer (GC), Siewert Type III Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction
Enrollment 400 participants
Start Date 2025-01-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-22