Gastric Cancer (GC)PROXISTATNCT07441785
Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer
An observational study of Gastric Cancer (GC) and Siewert Type III Adenocarcinoma of Esophagogastric Junction, run by P. Herzen Moscow Oncology Research Institute at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC), Siewert Type III Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Proximal Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2025to 1 Jun 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
P.Herzen Moscow Oncological Research Institute
Moscow
Andrey Ryabov, MD, PhD
Ilya Kolobaev, PhD
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Gastric Cancer (GC), Siewert Type III Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction
- Being tested
- Proximal Gastrectomy
- Keywords
- Proximal gastrectomy, Morbidity, Mortality, Quality of life, Surgery, Esophagogastric Junction Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal GastrectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with morbidity and mortality | Patients who suffered from any type of morbidity after surgery Receives: Procedure: Proximal Gastrectomy | |
| Patients without morbidity and mortality | Patients who did not suffered from any type of morbidity after surgery Receives: Procedure: Proximal Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 90 days after operation
Overall survival
Overall survival within 1 year after operation
Measured: 1 year after operation
Frequency of local recurrence
Frequency of local recurrence within 1 year after operation
Measured: 1 year after operation
Frequency of tumor progression
Frequency of tumor progression within 1 year after operation
Measured: 1 year after operation
Secondary outcomes (7)
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
Measured: 6 and 12 months after surgery
Incidence of development of esophageal anastomotic stricture
Incidence of development of esophageal anastomotic stricture in the postoperative period.
Measured: 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
Measured: 6 and 12 months after surgery
Pressure of the esophageal anastomosis
Pressure of the esophageal anastomosis in the postoperative period according to esophageal manometry
Measured: 6 and 12 months after surgery
The level of body weight reduction
The level of body weight reduction in the postoperative period
Measured: 6 and 12 months after surgery
The level of hemoglobin
The level of hemoglobin in 6 and 12 months after surgery
Measured: 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
Measured: 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- P. Herzen Moscow Oncology Research Institute
- Sponsor type
- Other government
- Collaborators
- A.Loginov Moscow Clinical Scientific Center
- Responsible party
- Principal investigator, Andrey Ryabov, P. Herzen Moscow Oncology Research Institute
- Investigators
- Andrey Ryabov, MD, PhD, Study director, P.Herzen Moscow Oncological Research InstituteVladimir Khomyakov, MD, PhD, Principal investigator, P.Herzen Moscow Oncological Research InstituteNuriddin Abdulkhakimov, PhD, Principal investigator, P.Herzen Moscow Oncological Research InstitutePavel Smirnov, Principal investigator, P.Herzen Moscow Oncological Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441785
- Sponsor's protocol ID
- 110-3
- Acronym
- PROXISTAT
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer
- ClinicalTrials.gov ID
- NCT07441785
- Acronym / sponsor ID
- PROXISTAT / 110-3
- Conditions
- Gastric Cancer (GC), Siewert Type III Adenocarcinoma of Esophagogastric Junction, Siewert Type II Adenocarcinoma of Esophagogastric Junction
- Keywords
- Proximal gastrectomy, Morbidity, Mortality, Quality of life, Surgery, Esophagogastric Junction Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- P. Herzen Moscow Oncology Research InstituteOther government
- Collaborators
- A.Loginov Moscow Clinical Scientific Center
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 2 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with morbidity and mortality | – | Procedure: Proximal GastrectomyPatients who suffered from any type of morbidity after surgery |
| Patients without morbidity and mortality | – | Procedure: Proximal GastrectomyPatients who did not suffered from any type of morbidity after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 GastrectomyResection of the upper third to one-half of the stomach and the distal portion of the esophagus with different types of digestive system reconstruction | Procedure or surgery | Patients with morbidity and mortality, Patients without morbidity and mortality |
Primary outcome
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
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.
Overall survival
Time frame: 1 year after operation
Overall survival within 1 year after operation
Frequency of local recurrence
Time frame: 1 year after operation
Frequency of local recurrence within 1 year after operation
Frequency of tumor progression
Time frame: 1 year after operation
Frequency of tumor progression within 1 year after operation
7 secondary outcomes
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
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 22 Apr 2026.
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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.
Andrey Ryabov, MD, PhD study director
P.Herzen Moscow Oncological Research Institute
Vladimir Khomyakov, MD, PhD principal investigator
P.Herzen Moscow Oncological Research Institute
Nuriddin Abdulkhakimov, PhD principal investigator
P.Herzen Moscow Oncological Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (GC) and Siewert Type III Adenocarcinoma of Esophagogastric Junction, run by P. Herzen Moscow Oncology Research Institute at 1 site in Russia.
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 1 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Andrey Ryabov, MD, PhD (+7 (495) 150-11-22, ryabovdoc@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 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 22 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.