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NCT Number: NCT07800819

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

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.

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Key information

Conditions

Gastric Adenocarcinoma Adenocarcinoma of the Esophagogastric Junction Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 75 years.
  • Histologically confirmed gastric adenocarcinoma or Siewert type II/III adenocarcinoma of the esophagogastric junction.
  • Underwent proximal gastrectomy with double-tract reconstruction.
  • Surgery performed with curative intent.
  • At least one valid postoperative follow-up record containing reflux, nutritional, or complication information.
  • Clinical, pathological, operative, and follow-up data sufficiently complete for analysis, with less than 20 percent missingness in key variables.

Exclusion criteria

  • Previous gastric or esophageal surgery, except limited endoscopic treatment such as endoscopic mucosal resection.
  • Synchronous or metachronous malignancy, except cured non-melanoma skin cancer or cervical carcinoma in situ.
  • Complete absence of follow-up data.
  • Double-tract reconstruction not completed or changed to another reconstruction method.
  • Severe preoperative reflux disease, defined as GERD-Q score greater than 8 with a requirement for long-term medication.

Treatment and study plan

Proximal gastrectomy with double-tract reconstruction

Procedure

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.

Primary outcomes

  1. Endoscopic reflux esophagitis

    Time frame: 1 year after surgery

    Presence and severity of reflux esophagitis assessed by endoscopy using the Los Angeles classification (grades A-D).

  2. Clinically significant reflux symptoms

    Time frame: 1 year after surgery

    Reflux symptoms assessed using the GERD-Q questionnaire; a total score greater than 8 is considered clinically significant reflux.

  3. Change in body mass index

    Time frame: From preoperative baseline to 1 year after surgery

    Change in body mass index, measured in kilograms per square meter.

  4. Change in serum albumin

    Time frame: From preoperative baseline to 1 year after surgery

    Change in serum albumin concentration, measured in grams per liter.

  5. Change in hemoglobin

    Time frame: From preoperative baseline to 1 year after surgery

    Change in hemoglobin concentration, measured in grams per liter.

Secondary outcomes

  1. Perioperative outcomes-Operative time

    Time frame: From surgery through hospital discharge, up to 6 months

    Operative time in minutes

  2. Postoperative complications

    Time frame: Within 30 days after surgery

    Overall complications, severe complications defined as Clavien-Dindo grade IIIa or higher, anastomotic leakage, and anastomotic stricture requiring endoscopic dilation or another intervention.

  3. Overall survival

    Time frame: From the date of surgery until death or last follow-up, up to 12 years

    Time from surgery to death from any cause. Participants alive at last follow-up will be censored.

  4. Disease-free survival

    Time frame: From the date of surgery until recurrence, death, or last follow-up, up to 12 years

    Time from surgery to first local, regional, or distant recurrence or death from any cause. Event-free participants will be censored at last follow-up.

  5. intraoperative blood loss

    Time frame: from surgery to discharge, up to 6 months

    intraoperative blood loss in milliliters

  6. postoperative length of hospital stay

    Time frame: from surgery to discharge, up to 6 months.

    postoperative length of hospital stay in days

  7. conversion to open surgery

    Time frame: from surgery to discharge, up to 6 months

    conversion to open surgery among patients undergoing minimally invasive surgery (percentage).

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Xu

CONTACT

[email protected]

+86-138-5153-0117

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Moscow Clinical Scientific Center named after A.S. Loginov

Registry information

Official study title

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

Acronym: RUSCHI-DTR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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