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

Surgical Outcomes and Long-Term Survival of Proximal Gastrectomy With Double-Tract Reconstruction at High-Volume Centers in Russia and China: A Two-Center Retrospective Analysis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07800819
Acronym
RUSCHI-DTR
Enrollment
250
Registered
2026-09-02
Start date
2026-08-15
Completion date
2027-08-15
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Esophagogastric Junction, Gastric Adenocarcinoma

Keywords

Proximal gastrectomy, Double-tract reconstruction, Reflux esophagitis, Postoperative nutrition

Brief 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.

Interventions

PROCEDUREProximal 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.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER
Moscow Clinical Scientific Center named after A.S. Loginov
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in serum albuminFrom preoperative baseline to 1 year after surgeryChange in serum albumin concentration, measured in grams per liter.
Change in hemoglobinFrom preoperative baseline to 1 year after surgeryChange in hemoglobin concentration, measured in grams per liter.
Endoscopic reflux esophagitis1 year after surgeryPresence and severity of reflux esophagitis assessed by endoscopy using the Los Angeles classification (grades A-D).
Clinically significant reflux symptoms1 year after surgeryReflux symptoms assessed using the GERD-Q questionnaire; a total score greater than 8 is considered clinically significant reflux.
Change in body mass indexFrom preoperative baseline to 1 year after surgeryChange in body mass index, measured in kilograms per square meter.

Secondary

MeasureTime frameDescription
Postoperative complicationsWithin 30 days after surgeryOverall complications, severe complications defined as Clavien-Dindo grade IIIa or higher, anastomotic leakage, and anastomotic stricture requiring endoscopic dilation or another intervention.
Disease-free survivalFrom the date of surgery until recurrence, death, or last follow-up, up to 12 yearsTime from surgery to first local, regional, or distant recurrence or death from any cause. Event-free participants will be censored at last follow-up.
Overall survivalFrom the date of surgery until death or last follow-up, up to 12 yearsTime from surgery to death from any cause. Participants alive at last follow-up will be censored.
intraoperative blood lossfrom surgery to discharge, up to 6 monthsintraoperative blood loss in milliliters
postoperative length of hospital stayfrom surgery to discharge, up to 6 months.postoperative length of hospital stay in days
conversion to open surgeryfrom surgery to discharge, up to 6 monthsconversion to open surgery among patients undergoing minimally invasive surgery (percentage).
Perioperative outcomes-Operative timeFrom surgery through hospital discharge, up to 6 monthsOperative time in minutes

Countries

China, Russia

Contacts

CONTACTHao Xu
hxu@njmu.edu.cn+86-138-5153-0117
PRINCIPAL_INVESTIGATORHao Xu

The First Affiliated Hospital with Nanjing Medical University

PRINCIPAL_INVESTIGATORRoman Izrailov

Moscow Clinical Scientific Center named after A.S. Loginov

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026