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Not yet recruitingNCT07800819RUSCHI-DTRUpdated Sep 2, 2026

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

An observational study in Gastric Adenocarcinoma and Adenocarcinoma of the Esophagogastric Junction, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
250
Ages
18 Years to 75 Years
Sex
All
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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.

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Conditions studied

  • Gastric Adenocarcinoma
  • Adenocarcinoma of the Esophagogastric Junction

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Keywords

  • Proximal gastrectomy
  • Double-tract reconstruction
  • Reflux esophagitis
  • Postoperative nutrition
03

In context

Esophagitis, Peptic

83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.

This study's planned enrollment of 250 is below the median of 535 across 22 observational studies indexed under Esophagitis, Peptic.

Browse Esophagitis, Peptic studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated from June 2015 through June 2025 at either participating center who underwent curative proximal gastrectomy with double-tract reconstruction for proximal gastric adenocarcinoma or Siewert type II/III adenocarcinoma of the esophagogastric junction.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 75 years.
  2. 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

Exclusion Criteria:

  1. Previous gastric or esophageal surgery, except limited endoscopic treatment such as endoscopic mucosal resection.
  2. Synchronous or metachronous , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chinese cohort

    Patients treated at the First Affiliated Hospital of Nanjing Medical University who underwent proximal gastrectomy with double-tract reconstruction during the study source period.

    Procedure: Proximal gastrectomy with double-tract reconstruction

  • Russian cohort

    Patients treated at the Moscow Clinical Scientific Center named after A.S. Loginov who underwent proximal gastrectomy with double-tract reconstruction during the study source period.

    Procedure: Proximal gastrectomy with double-tract reconstruction

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.

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What researchers measure

Primary outcomes

  1. Endoscopic reflux esophagitis

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

    Time frame: 1 year after surgery

  2. Clinically significant reflux symptoms

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

    Time frame: 1 year after surgery

  3. Change in body mass index

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

    Time frame: From preoperative baseline to 1 year after surgery

  4. Change in serum albumin

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

    Time frame: From preoperative baseline to 1 year after surgery

  5. Change in hemoglobin

    Change in hemoglobin concentration, measured in grams per liter.

    Time frame: From preoperative baseline to 1 year after surgery

Secondary outcomes

  1. Perioperative outcomes-Operative time

    Operative time in minutes

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

  2. Postoperative complications

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

    Time frame: Within 30 days after surgery

  3. Overall survival

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

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

  4. Disease-free survival

    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.

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

  5. intraoperative blood loss

    intraoperative blood loss in milliliters

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

  6. postoperative length of hospital stay

    postoperative length of hospital stay in days

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

  7. conversion to open surgery

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

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

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Study locations

2 sites
  • First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
  • Moscow Clinical Scientific Center named after A.S. Loginov
    Moscow, Russia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07800819
Collaborators
Moscow Clinical Scientific Center named after A.S. Loginov
Responsible party
Hao Xu (Dr., The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Sep 2, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Jun 15, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Hao Xu
Contact
hxu@njmu.edu.cn
+86-138-5153-0117
Hao Xu
principal investigator · The First Affiliated Hospital with Nanjing Medical University
Roman Izrailov
principal investigator · Moscow Clinical Scientific Center named after A.S. Loginov

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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