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

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.

Study Overview

• Status: Recruiting
• Conditions: Siewert Type II Adenocarcinoma of Esophagogastric Junction; Gastric Cancer (GC); Siewert Type III Adenocarcinoma of Esophagogastric Junction
• Intervention / Treatment: Procedure: Proximal Gastrectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Andrey Ryabov, MD, PhD; Phone Number: +7 (495) 150-11-22; Email: ryabovdoc@mail.ru

Study Locations

• Russia
  • Moscow, Russia
    • Recruiting
    • P.Herzen Moscow Oncological Research Institute
    • Contact: Andrey Ryabov, MD, PhD
    • Sub-Investigator: Ilya Kolobaev, PhD
    • Sub-Investigator: Anton Kollontai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with morbidity and mortality; Patients who suffered from any type of morbidity after surgery	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
Patients without morbidity and mortality; Patients who did not suffered from any type of morbidity after surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of development and the severity of reflux esophagitis	Incidence of development and the severity (degree of expression) of reflux esophagitis according to the Los Angeles classification in the postoperative period	6 and 12 months after surgery
Incidence of development of esophageal anastomotic stricture	Incidence of development of esophageal anastomotic stricture in the postoperative period.	6 and 12 months after surgery
Incidence and severity of dumping syndrome	Incidence and severity of dumping syndrome, along with quality of life assessment in the postoperative period according to the KOQUSS-40 questionnaire at 6 and 12 months postoperatively	6 and 12 months after surgery
Pressure of the esophageal anastomosis	Pressure of the esophageal anastomosis in the postoperative period according to esophageal manometry	6 and 12 months after surgery
The level of body weight reduction	The level of body weight reduction in the postoperative period	6 and 12 months after surgery
The level of hemoglobin	The level of hemoglobin in 6 and 12 months after surgery	6 and 12 months after surgery
Food passage rate through the esophagus and the stump of the stomach	The rate of passage of food through the esophagus and the stump of the stomach, as well as evacuation from the stump of the stomach into the small intestine based on scintigraphy of the stomach and esophagus after 12 months after surgery	6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: P. Herzen Moscow Oncology Research Institute
• Collaborators: A.Loginov Moscow Clinical Scientific Center
• Investigators: Study Director: Andrey Ryabov, MD, PhD, P.Herzen Moscow Oncological Research Institute; Principal Investigator: Vladimir Khomyakov, MD, PhD, P.Herzen Moscow Oncological Research Institute; Principal Investigator: Pavel Smirnov, P.Herzen Moscow Oncological Research Institute; Principal Investigator: Nuriddin Abdulkhakimov, PhD, P.Herzen Moscow Oncological Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; Quality of life; Morbidity; Mortality; Proximal gastrectomy; Esophagogastric Junction Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 110-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No