Trial Title:
Postoperative Morbidity and Mortality After Gastric Cancer Surgery
NCT ID:
NCT06277908
Condition:
Gastric Cancer
Siewert Type III Adenocarcinoma of Esophagogastric Junction
Stomach Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric cancer
Surgery
Morbidity
Mortality
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Elective Surgery for gastric cancer
Description:
Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach
Arm group label:
Patients with morbidity
Arm group label:
Patients without morbidity
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. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
A.S. Loginov Moscow Clinical Scientific Center
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Roman Izrailov
Contact backup:
Last name:
Nikolay Semenov
Facility:
Name:
A.Tsyb Medical Radiological Research Centre
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
I.M. Sechenov First Moscow State Medical University
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
P.Herzen Moscow Oncological Research Institute
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Andrey Ryabov
Contact backup:
Last name:
Nuriddin Abdulkhakimov
Facility:
Name:
Petrovsky National Research Centre of Surgery
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
Vishnevsky National Medical Research Center of Surgery
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
Nizhny Novgorod Regional Clinical Oncological Dispensary
Address:
City:
Nizhny Novgorod
Country:
Russian Federation
Facility:
Name:
National Medical Research Centre for Oncology
Address:
City:
Rostov-on-Don
Country:
Russian Federation
Facility:
Name:
Petrov National Medical Research Center of Oncology
Address:
City:
Saint Petersburg
Country:
Russian Federation
Start date:
March 18, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
P. Herzen Moscow Oncology Research Institute
Agency class:
Other
Collaborator:
Agency:
National Medical Research Radiological Centre of the Ministry of Health of Russia
Agency class:
Other
Source:
P. Herzen Moscow Oncology Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277908
