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Starting soon Observational

Sino-Russian Comparison of Outcomes After Proximal Gastrectomy With Double-Tract Reconstruction

NCT07800819 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-08-15
Last updated
2026-09-02

Condition(s) studied

Gastric AdenocarcinomaAdenocarcinoma of the Esophagogastric Junction

Investigational drug(s) / intervention(s)

Proximal gastrectomy with double-tract reconstruction

Proximal gastrectomy with double-tract reconstruction: Curative proximal gastrectomy followed by double-tract reconstruction performed as part of routine clinical care. The study does not assign treatment and retrospectively analyzes existing clinical data.

Study summary

This two-center retrospective observational cohort study compares Chinese and Russian patients who underwent curative proximal gastrectomy with double-tract reconstruction for proximal gastric adenocarcinoma or Siewert type II/III adenocarcinoma of the esophagogastric junction. The study evaluates postoperative reflux, nutritional status, perioperative outcomes, complications, and long-term survival. Propensity score matching will be used to improve comparability between the two cohorts.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 to 75 years. 2. Histologically confirmed gastric adenocarcinoma or Siewert type II/III adenocarcinoma of the esophagogastric junction. 3. Underwent proximal gastrectomy with double-tract reconstruction. 4. Surgery performed with curative intent. 5. At least one valid postoperative follow-up record containing reflux, nutritional, or complication information. 6. Clinical, pathological, operative, and follow-up data sufficiently complete for analysis, with less than 20 percent missingness in key variables. Exclusion Criteria: 1. Previous gastric or esophageal surgery, except limited endoscopic treatment such as endoscopic mucosal resection. 2. Synchronous or metachronous malignancy, except cured non-melanoma skin cancer or cervical carcinoma in situ. 3. Complete absence of follow-up data. 4. Double-tract reconstruction not completed or changed to another reconstruction method. 5. Severe preoperative reflux disease, defined as GERD-Q score greater than 8 with a requirement for long-term medication.

Primary outcome measure(s)

  • Endoscopic reflux esophagitis — 1 year after surgery
    Presence and severity of reflux esophagitis assessed by endoscopy using the Los Angeles classification (grades A-D).
  • Clinically significant reflux symptoms — 1 year after surgery
    Reflux symptoms assessed using the GERD-Q questionnaire; a total score greater than 8 is considered clinically significant reflux.
  • Change in body mass index — From preoperative baseline to 1 year after surgery
    Change in body mass index, measured in kilograms per square meter.
  • Change in serum albumin — From preoperative baseline to 1 year after surgery
    Change in serum albumin concentration, measured in grams per liter.
  • Change in hemoglobin — From preoperative baseline to 1 year after surgery
    Change in hemoglobin concentration, measured in grams per liter.

Trial sites (2)

FacilityCityRegionStatus
First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Moscow Clinical Scientific Center named after A.S. Loginov Moscow Russia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07800819 on ClinicalTrials.gov ↗ ← All trials in China