Gastric CancerGASTROSTATNCT06277908
Postoperative Morbidity and Mortality After Gastric Cancer Surgery
An observational study of Gastric Cancer and Siewert Type III Adenocarcinoma of Esophagogastric Junction, run by P. Herzen Moscow Oncology Research Institute at 9 sites in Russia.
Trial summary
Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Siewert Type III Adenocarcinoma of Esophagogastric Junction, Stomach Cancer
- What is being tested?
- Elective Surgery for gastric cancer
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 9 sitesRussia
- Study dates
- 18 Mar 2024to 31 Dec 2024
- 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 primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024.
Who may be able to join
- All consecutive patients with primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) 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 previous staging laparoscopy,
- Patients with known synchronous cancer;
- Patients with Gastrointestinal stromal tumors (GIST)
- Presence of gastroesophageal junction (Siewert I and II) malignancy;
- Patients submitted to Emergency surgery or surgery without curative intent;
- Patients undergoing additional surgery (except cholecystectomy) along with surgery for gastric cancer.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
A.S. Loginov Moscow Clinical Scientific Center
Moscow
Roman Izrailov
Nikolay Semenov
A.Tsyb Medical Radiological Research Centre
Moscow
I.M. Sechenov First Moscow State Medical University
Moscow
P.Herzen Moscow Oncological Research Institute
Moscow
Andrey Ryabov
Nuriddin Abdulkhakimov
Petrovsky National Research Centre of Surgery
Moscow
Vishnevsky National Medical Research Center of Surgery
Moscow
Nizhny Novgorod Regional Clinical Oncological Dispensary
Nizhny Novgorod
National Medical Research Centre for Oncology
Rostov-on-Don
Petrov National Medical Research Center of Oncology
Saint Petersburg
About this study
Official title: 90-day Postoperative Morbidity and Mortality After Elective Surgery for Gastric Cancer
Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
Read the detailed description
According to 2018 World Health Organization (WHO) data, gastric cancer is the fourth most common malignant disease and the third leading cause of cancer-related deaths worldwide. Surgery with lymphadenectomy remains the standard of care. Despite significant changes in gastric cancer treatment protocols, surgery is still associated with high risks of complications, with rates varying from clinic to clinic. And currently, the use of multimodal treatments and standardization of surgical procedures are proposed as strategies to improve outcomes. In addition, the use of laparoscopic and robotic techniques have been proposed to provide better short-term results compared to open surgery and comparable long-term oncological outcomes. Randomized trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. While mortality is easier to quantify, there are no standardized criteria for calculating postoperative complication rates. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
- Conditions
- Gastric Cancer, Siewert Type III Adenocarcinoma of Esophagogastric Junction, Stomach Cancer
- Being tested
- Elective Surgery for gastric cancer
- Keywords
- Gastric cancer, Surgery, Morbidity, Mortality
- Medical subject headings
- Stomach 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
Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach
| Study group | Role | What they receive |
|---|---|---|
| Patients with morbidity | Patients who suffered from any type of morbidity after surgery Receives: Procedure: Elective Surgery for gastric cancer | |
| Patients without morbidity | 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: anastomotic leak, postoperative bleeding requiring invasive treatment, other complications requiring re-intervention or other invasive procedure, postoperative bowel obstruction, postoperative pancreatic fistula, duodenal leak, gastrostasis, postoperative pancreatitis, postoperative bowel perforation or necrosis, non-surgical infections, pleural effusion requiring drainage, respiratory failure requiring reintubation, acute renal failure requiring hemofiltration/dialysis, need for prolonged intubation, need for tracheostomy, need for cardiopulmonary resuscitation, pulmonary embolism, pneumothorax requiring treatment, myocardial infarction, acute myocardial failure, cardiac dysrhythmia requiring invasive treatment, stroke, acute liver dysfunction, other 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 (estimated)
- Primary completion18 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- 700 participants (estimated)
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
- NCT06277908
- Sponsor's protocol ID
- 110-1
- Acronym
- GASTROSTAT
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. 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 Gastric Cancer
- ClinicalTrials.gov ID
- NCT06277908
- Acronym / sponsor ID
- GASTROSTAT / 110-1
- Conditions
- Gastric Cancer, Siewert Type III Adenocarcinoma of Esophagogastric Junction, Stomach Cancer
- Keywords
- Gastric cancer, Surgery, Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- 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 (estimated)
- Primary completion
- 18 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- 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.
Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
Detailed description
According to 2018 World Health Organization (WHO) data, gastric cancer is the fourth most common malignant disease and the third leading cause of cancer-related deaths worldwide. Surgery with lymphadenectomy remains the standard of care. Despite significant changes in gastric cancer treatment protocols, surgery is still associated with high risks of complications, with rates varying from clinic to clinic. And currently, the use of multimodal treatments and standardization of surgical procedures are proposed as strategies to improve outcomes. In addition, the use of laparoscopic and robotic techniques have been proposed to provide better short-term results compared to open surgery and comparable long-term oncological outcomes. Randomized trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. While mortality is easier to quantify, there are no standardized criteria for calculating postoperative complication rates. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 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 | – | Procedure: Elective Surgery for gastric cancerPatients who suffered from any type of morbidity after surgery |
| Patients without morbidity | – | 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 primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024.
Key inclusion criteria (1 listed)
- All consecutive patients with primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024.
Key exclusion criteria (6 listed)
- Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on previous staging laparoscopy,
- Patients with known synchronous cancer;
- Patients with Gastrointestinal stromal tumors (GIST)
- Presence of gastroesophageal junction (Siewert I and II) malignancy;
- Patients submitted to Emergency surgery or surgery without curative intent;
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 cancerTotal, distal or proximal gastrectomy via open, laparoscopic or robotic approach | Procedure or surgery | Patients with morbidity, Patients without morbidity |
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: anastomotic leak, postoperative bleeding requiring invasive treatment, other complications requiring re-intervention or other invasive procedure, postoperative bowel obstruction, postoperative pancreatic fistula, duodenal leak, gastrostasis, postoperative pancreatitis, postoperative bowel perforation or necrosis, non-surgical infections, pleural effusion requiring drainage, respiratory failure requiring reintubation, acute renal failure requiring hemofiltration/dialysis, need for prolonged intubation, need for tracheostomy, need for cardiopulmonary resuscitation, pulmonary embolism, pneumothorax requiring treatment, myocardial infarction, acute myocardial failure, cardiac dysrhythmia requiring invasive treatment, stroke, acute liver dysfunction, other 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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
9 sites 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 and Siewert Type III Adenocarcinoma of Esophagogastric Junction, run by P. Herzen Moscow Oncology Research Institute at 9 sites 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 6 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
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 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 26 Feb 2024.