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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Proximal gastrectomy with double-tract reconstruction

    Procedure/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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Chinese cohort1 intervention
Group B: Russian cohort1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Moscow Clinical Scientific Center named after A.S. Loginov

Collaborator

This trial is not recruiting at the moment. You can still explore other options: