Gastric AdenocarcinomaRUSCHI-DTRNCT07800819
Sino-Russian Comparison of Outcomes After Proximal Gastrectomy With Double-Tract Reconstruction
An observational study of Gastric Adenocarcinoma and Adenocarcinoma of the Esophagogastric Junction, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Adenocarcinoma of the Esophagogastric Junction
- What is being tested?
- Proximal gastrectomy with double-tract reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Aug 2026to 15 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official 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
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.
- Being tested
- Proximal gastrectomy with double-tract reconstruction
- Keywords
- Proximal gastrectomy, Double-tract reconstruction, Reflux esophagitis, Postoperative nutrition
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal gastrectomy with double-tract reconstructionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Proximal gastrectomy with double-tract reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic reflux esophagitis
Presence and severity of reflux esophagitis assessed by endoscopy using the Los Angeles classification (grades A-D).
Measured: 1 year after surgery
Clinically significant reflux symptoms
Reflux symptoms assessed using the GERD-Q questionnaire; a total score greater than 8 is considered clinically significant reflux.
Measured: 1 year after surgery
Change in body mass index
Change in body mass index, measured in kilograms per square meter.
Measured: From preoperative baseline to 1 year after surgery
Change in serum albumin
Change in serum albumin concentration, measured in grams per liter.
Measured: From preoperative baseline to 1 year after surgery
Change in hemoglobin
Change in hemoglobin concentration, measured in grams per liter.
Measured: From preoperative baseline to 1 year after surgery
Secondary outcomes (7)
Perioperative outcomes-Operative time
Operative time in minutes
Measured: From surgery through hospital discharge, up to 6 months
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.
Measured: Within 30 days after surgery
Overall survival
Time from surgery to death from any cause. Participants alive at last follow-up will be censored.
Measured: From the date of surgery until death or last follow-up, up to 12 years
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.
Measured: From the date of surgery until recurrence, death, or last follow-up, up to 12 years
intraoperative blood loss
intraoperative blood loss in milliliters
Measured: from surgery to discharge, up to 6 months
postoperative length of hospital stay
postoperative length of hospital stay in days
Measured: from surgery to discharge, up to 6 months.
conversion to open surgery
conversion to open surgery among patients undergoing minimally invasive surgery (percentage).
Measured: from surgery to discharge, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Moscow Clinical Scientific Center named after A.S. Loginov
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hao Xu, Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityRoman Izrailov, Principal investigator, Moscow Clinical Scientific Center named after A.S. Loginov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800819
- Sponsor's protocol ID
- RUSCHI-DTR
- Acronym
- RUSCHI-DTR
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07800819
- Acronym / sponsor ID
- RUSCHI-DTR / RUSCHI-DTR
- Keywords
- Proximal gastrectomy, Double-tract reconstruction, Reflux esophagitis, Postoperative nutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Moscow Clinical Scientific Center named after A.S. Loginov
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese cohort | – | Procedure: Proximal gastrectomy with double-tract reconstructionPatients treated at the First Affiliated Hospital of Nanjing Medical University who underwent proximal gastrectomy with double-tract reconstruction during the study source period. |
| Russian cohort | – | Procedure: Proximal gastrectomy with double-tract reconstructionPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal gastrectomy with double-tract reconstructionCurative 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. | Procedure or surgery | Chinese cohort, Russian cohort |
Primary outcome
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).
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.
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.
Change in serum albumin
Time frame: From preoperative baseline to 1 year after surgery
Change in serum albumin concentration, measured in grams per liter.
Change in hemoglobin
Time frame: From preoperative baseline to 1 year after surgery
Change in hemoglobin concentration, measured in grams per liter.
7 secondary outcomes
Perioperative outcomes-Operative time
Time frame: From surgery through hospital discharge, up to 6 months
Postoperative complications
Time frame: Within 30 days after surgery
Overall survival
Time frame: From the date of surgery until death or last follow-up, up to 12 years
Disease-free survival
Time frame: From the date of surgery until recurrence, death, or last follow-up, up to 12 years
intraoperative blood loss
Time frame: from surgery to discharge, up to 6 months
postoperative length of hospital stay
Time frame: from surgery to discharge, up to 6 months.
conversion to open surgery
Time frame: from surgery to discharge, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma and Adenocarcinoma of the Esophagogastric Junction, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Xu (+86-138-5153-0117, hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic reflux esophagitis (time frame: 1 year after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.