Esophageal CancerESOSTATNCT06277921
Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery
An observational study of Esophageal Cancer and Oesophageal Cancer, run by P. Herzen Moscow Oncology Research Institute at 18 sites in 2 countries.
Trial summary
Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure. However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Oesophageal Cancer, Siewert Type I Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Elective Surgery for gastric cancer
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 18 Mar 2024to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach
Who may be able to join
- All consecutive patients with clinically documented primary Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024
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 III 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
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Russia17 sites
Bryansk Regional Oncological Hospital
Bryansk
Cheboksary Republican Clinical Oncology Dispensary
Cheboksary
M.Sigal Republican Medical Oncology Dispensary
Kazan'
A.Loginov Moscow Clinical Scientific Center
Moscow
Moscow City Oncology Hospital № 62
Moscow
P.Herzen Moscow Oncological Research Institute
Moscow
S.Yudin Moscow Oncological Center No.1
Moscow
University Clinical Hospital №1 of Sechenov University
Moscow
University Clinical Hospital №4 of Sechenov University
Moscow
Vishnevsky National Medical Research Center of Surgery
Moscow
Nizhny Novgorod Regional Clinical Oncological Dispensary
Nizhny Novgorod
Novosibirsk Regional Clinical Oncology Dispensary
Novosibirsk
A.Tsyb Medical Radiological Research Centre
Obninsk
Rostov-on-Don National Medical Research Centre for Oncology
Rostov-on-Don
Leningrad Regional Clinical Hospital
Saint Petersburg
Saratov Regional Clinical Oncological Dispensary
Saratov
Ufa Republican Clinical Oncology Dispensary
Ufa
About this study
Official title: 90-day Postoperative Morbidity and Mortality After Elective Surgery for Esophageal and Esophagogastric Junction Cancer
Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.
However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
Read the detailed description
Esophageal and esophago-gastric junction cancer is the seventh most common malignancy and the sixth leading cause of cancer-related mortality worldwide.
Surgery remains the primary treatment for esophageal cancer and is one of the most technically challenging interventions in oncological surgery. In addition, esophagectomy is associated with high risks of postoperative complications, with rates varying from clinic to clinic. Esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively.
The problem with the available studies of the course of the postoperative period is the significant heterogeneity of research methods, which does not allow us to obtain a true picture of the results of surgical treatment of the esophagus and esophagogastric junction cancer in the Russian Federation.
To improve the quality of further studies and recommendations on standardization of surgical treatment of esophageal and esophagogastric junction cancer and its morbidity, there is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
- Conditions
- Esophageal Cancer, Oesophageal Cancer, Siewert Type I Adenocarcinoma of Esophagogastric Junction, Siewert Type III Adenocarcinoma of Esophagogastric Junction
- Being tested
- Elective Surgery for gastric cancer
- Keywords
- Esophageal Cancer, Esophagogastric Junction Cancer, Morbidity, Mortality, Surgery
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Surgery for gastric cancerProcedure or surgery
Also called Esophageal or Esophagogastric Junction Cancer
Resection of the esophagus and the gastroesophageal junction via open, laparoscopic or robotic approach
| Study group | Role | What they receive |
|---|---|---|
| Patients with morbidity and mortality | Patients who suffered from any type of morbidity after surgery Receives: Procedure: Elective Surgery for gastric cancer | |
| Patients without morbidity and mortality | Patients who did not suffer from any type of morbidity after surgery Receives: Procedure: Elective Surgery for gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
the type of complications and the incidence of it
the types of complication is classified into as follows: gastrointestinal (anastomotic leak, conduit necrosis/failure, pancreatitis, GI Bleeding, delayed conduit emptying); pulmonary (pneumonia, pleural effusion, pneumothorax, respiratory failure, ARDS, acute aspiration, tracheobronchial Injury); cardiac; thromboembolic; urologic; infection (wound infection; intrathoracic/intra-abdominal abscess; generalized sepsis; other infections); neurologic (recurrent nerve injury, acute delirium) and other (thoracic wound dehiscence, diaphragmatic hernia, chyle leak, reoperation other than for anastomotic leak or conduit necrosis, multiple organ dysfunction syndrome) complications Each complication will be graded according to Clavien-Dindo classification. Re-admission or visiting emergency room will be checked and recorded.
Measured: within 90 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start18 Mar 2024
- Primary completion18 Sep 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- P. Herzen Moscow Oncology Research Institute
- Sponsor type
- Other government
- Collaborators
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- 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, MD, 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
- NCT06277921
- Sponsor's protocol ID
- 110-2
- Acronym
- ESOSTAT
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2024
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 90-day Postoperative Morbidity and Mortality After Elective Surgery for Esophageal and Esophagogastric Junction Cancer
- ClinicalTrials.gov ID
- NCT06277921
- Acronym / sponsor ID
- ESOSTAT / 110-2
- Conditions
- Esophageal Cancer, Oesophageal Cancer, Siewert Type I Adenocarcinoma of Esophagogastric Junction, Siewert Type III Adenocarcinoma of Esophagogastric Junction
- Keywords
- Esophageal Cancer, Esophagogastric Junction Cancer, Morbidity, Mortality, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- P. Herzen Moscow Oncology Research InstituteOther government
- Collaborators
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 26 Feb 2024 (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.
Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.
However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
Detailed description
Esophageal and esophago-gastric junction cancer is the seventh most common malignancy and the sixth leading cause of cancer-related mortality worldwide.
Surgery remains the primary treatment for esophageal cancer and is one of the most technically challenging interventions in oncological surgery. In addition, esophagectomy is associated with high risks of postoperative complications, with rates varying from clinic to clinic. Esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively.
The problem with the available studies of the course of the postoperative period is the significant heterogeneity of research methods, which does not allow us to obtain a true picture of the results of surgical treatment of the esophagus and esophagogastric junction cancer in the Russian Federation.
To improve the quality of further studies and recommendations on standardization of surgical treatment of esophageal and esophagogastric junction cancer and its morbidity, there is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with morbidity and mortality | – | Procedure: Elective Surgery for gastric cancerPatients who suffered from any type of morbidity after surgery |
| Patients without morbidity and mortality | – | Procedure: Elective Surgery for gastric cancerPatients who did not suffer 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 Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach
Key inclusion criteria (1 listed)
- All consecutive patients with clinically documented primary Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024
Key exclusion criteria (4 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 III 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
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 |
|---|---|---|
| Elective Surgery for gastric cancerAlso: Esophageal or Esophagogastric Junction CancerResection of the esophagus and the gastroesophageal junction via open, laparoscopic or robotic approach | Procedure or surgery | Patients with morbidity and mortality, Patients without morbidity and mortality |
Primary outcome
the type of complications and the incidence of it
Time frame: within 90 days after operation
the types of complication is classified into as follows: gastrointestinal (anastomotic leak, conduit necrosis/failure, pancreatitis, GI Bleeding, delayed conduit emptying); pulmonary (pneumonia, pleural effusion, pneumothorax, respiratory failure, ARDS, acute aspiration, tracheobronchial Injury); cardiac; thromboembolic; urologic; infection (wound infection; intrathoracic/intra-abdominal abscess; generalized sepsis; other infections); neurologic (recurrent nerve injury, acute delirium) and other (thoracic wound dehiscence, diaphragmatic hernia, chyle leak, reoperation other than for anastomotic leak or conduit necrosis, multiple organ dysfunction syndrome) complications Each complication will be graded according to Clavien-Dindo classification. Re-admission or visiting emergency room will be checked and recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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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. This study is not recruiting at the moment.
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, MD, PhD principal investigator
P.Herzen Moscow Oncological Research Institute
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Oesophageal Cancer, run by P. Herzen Moscow Oncology Research Institute at 18 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia, Belarus. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the type of complications and the incidence of it (time frame: within 90 days after operation). 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 2 Jul 2025.