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Recruiting NCT07441785

Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proximal Gastrectomy.
Who it may be relevant to
Registry conditions: Gastric Cancer (GC), Siewert Type III Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Proximal gastric and esophagogastric junction cancer account for up to 40% of all gastric malignancies. For localized disease, proximal gastrectomy remains the primary radical surgical procedure. However, roconstruction of gastrointestinal continuity after this procedure is associated with significant functional disturbances.

The increasing frequency of proximal resections and expanding indications have heightened focus on postoperative quality of life (QoL). Currently used reconstruction techniques include direct esophagogastrostomy (in various modifications), double-tract reconstruction, jejunal interposition, and emerging anti-reflux esophagogastric anastomoses (e.g., double-flap technique, single-overlap, tunnel reconstruction, etc).

Each method carries distinct advantages and disadvantages concerning reflux esophagitis, food passage, dumping syndrome, nutritional status alterations, and long-term QoL.

Despite this variety, no universal consensus exists regarding the optimal reconstruction technique, resulting in heterogeneous surgical practices and variable functional outcomes. Most studies prioritize oncologic radicality and overall survival, whereas functional results and QoL remain under-investigated.

To enhance patient QoL, advance research, and standardize treatment of proximal gastric and esophagogastric junction cancers in the Russian Federation, there is a clear need for systematic evaluation of functional outcomes across different reconstruction types following proximal subtotal gastrectomy.

Interventions

  • Procedure Proximal Gastrectomy
    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

Primary outcome measures

  • The structure and frequency of postoperative complications depending on the method of reconstruction, as well as neoadjuvant treatment [Time frame: within 90 days after operation]
  • Overall survival [Time frame: 1 year after operation]
  • Frequency of local recurrence [Time frame: 1 year after operation]
  • Frequency of tumor progression [Time frame: 1 year after operation]
Secondary outcome measures (7)
  • Incidence of development and the severity of reflux esophagitis [Time frame: 6 and 12 months after surgery]
  • Incidence of development of esophageal anastomotic stricture [Time frame: 6 and 12 months after surgery]
  • Incidence and severity of dumping syndrome [Time frame: 6 and 12 months after surgery]
  • Pressure of the esophageal anastomosis [Time frame: 6 and 12 months after surgery]
  • The level of body weight reduction [Time frame: 6 and 12 months after surgery]
  • The level of hemoglobin [Time frame: 6 and 12 months after surgery]
  • Food passage rate through the esophagus and the stump of the stomach [Time frame: 6 and 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 1 center
  • P.Herzen Moscow Oncological Research Institute — Moscow

Identifiers

NCT: NCT07441785 · 110-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗