NCT07441785

Brief Summary

Proximal gastric and esophagogastric junction cancers comprise up to 40% of gastric malignancies. For localized disease, proximal gastrectomy is the main radical procedure, but reconstruction of GI tract often leads to significant functional issues. Rising use of proximal resections and broader indications have increased attention to postoperative quality of life (QoL). Common reconstructions include direct esophagogastrostomy (various types), double-tract reconstruction, jejunal interposition, and newer anti-reflux anastomoses (e.g., double-flap, overlap, tunnel techniques). Each method has unique pros and cons regarding reflux esophagitis, food passage, dumping syndrome, nutritional changes, and long-term QoL. No consensus exists on the optimal technique, leading to variable practices and outcomes. Most research focuses on oncologic radicality and survival, while functional results and QoL remain understudied. Systematic evaluation of functional outcomes across reconstruction types after proximal subtotal gastrectomy is needed in Russian Federation to improve QoL, advance research, and standardize treatment of proximal gastric and EGJ cancers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2025Jun 2029

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

February 24, 2026

Last Update Submit

April 17, 2026

Conditions

Gastric Cancer (GC)Siewert Type III Adenocarcinoma of Esophagogastric JunctionSiewert Type II Adenocarcinoma of Esophagogastric Junction

Keywords

Proximal gastrectomyMorbidityMortalityQuality of lifeSurgeryEsophagogastric Junction Cancer

Outcome Measures

Primary Outcomes (4)

  • The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment

    the types of complication is classified into as follows: esophageal anastomotic leak requiring surgical treatment, esophageal anastomotic leak not requiring surgical treatment, gastric stump necrosis, postoperative bleeding requiring surgical treatment, postoperative bleeding not requiring surgical treatment, postoperative ileum, postoperative pancreatic fistula type B, postoperative pancreatic fistula type C, duodenal stump leak / duodenal stump insufficiency, impaired evacuation from the gastric stump (more than 10 days after surgery), postoperative intestinal perforation or necrosis, persistent air leak through the pleural drain, wound dehiscence (evisceration, hernia), incarcerated diaphragmatic hernia, chylothorax or other types of lymph leakage, infectious complications of the postoperative wound, other complications requiring repeat intervention or another invasive procedure, other.

    within 90 days after operation

  • Overall survival

    Overall survival within 1 year after operation

    1 year after operation

  • Frequency of local recurrence

    Frequency of local recurrence within 1 year after operation

    1 year after operation

  • Frequency of tumor progression

    Frequency of tumor progression within 1 year after operation

    1 year after operation

Secondary Outcomes (7)

  • Incidence of development and the severity of reflux esophagitis

    6 and 12 months after surgery

  • Incidence of development of esophageal anastomotic stricture

    6 and 12 months after surgery

  • Incidence and severity of dumping syndrome

    6 and 12 months after surgery

  • Pressure of the esophageal anastomosis

    6 and 12 months after surgery

  • The level of body weight reduction

    6 and 12 months after surgery

  • +2 more secondary outcomes

Study Arms (2)

Patients with morbidity and mortality

Patients who suffered from any type of morbidity after surgery

Procedure: Proximal Gastrectomy

Patients without morbidity and mortality

Patients who did not suffered from any type of morbidity after surgery

Procedure: Proximal Gastrectomy

Interventions

Proximal GastrectomyPROCEDURE

Resection of the upper third to one-half of the stomach and the distal portion of the esophagus with different types of digestive system reconstruction

Patients with morbidity and mortalityPatients without morbidity and mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert II and III) cT1-3N0-2M0undergoing elective proximal gastrectomy curative intent - via open, laparoscopic or robotic approach

You may qualify if:

  • All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert I and II) cT1-3N0-2M0 undergoing proximal gastrectomy with curative intent - via open, laparoscopic or robotic approach between 01th January 2025 and 31th December 2026

You may not qualify if:

  • Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on a previous staging laparoscopy, or those with known synchronous other cancers.
  • Esophagogastric Junction Siewert I malignancy
  • Patients submitted to Emergency surgery or surgery without curative intent
  • Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy
  • Patients who have previously undergone surgery on the stomach or colon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

P.Herzen Moscow Oncological Research Institute

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Andrey Ryabov, MD, PhD

    P.Herzen Moscow Oncological Research Institute

    STUDY DIRECTOR

  • Vladimir Khomyakov, MD, PhD

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR

  • Nuriddin Abdulkhakimov, PhD

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR

  • Pavel Smirnov

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrey Ryabov, MD, PhD

CONTACT

+7 (495) 150-11-22ryabovdoc@mail.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Thoracoabdominal Oncology

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

RU(1)