Postoperative Morbidity and Mortality After Gastric Cancer Surgery
- Conditions
- Siewert Type III Adenocarcinoma of Esophagogastric JunctionStomach CancerGastric Cancer
- Interventions
- Procedure: Elective Surgery for gastric cancer
- Registration Number
- NCT06277908
- Lead Sponsor
- P. Herzen Moscow Oncology Research Institute
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 700
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with morbidity Elective Surgery for gastric cancer Patients who suffered from any type of morbidity after surgery Patients without morbidity Elective Surgery for gastric cancer Patients who did not suffer from any type of morbidity after surgery
- Primary Outcome Measures
Name Time Method the type of complications and the incidence of it 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
A.Tsyb Medical Radiological Research Centre
🇷🇺Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University
🇷🇺Moscow, Russian Federation
National Medical Research Centre for Oncology
🇷🇺Rostov-on-Don, Russian Federation
Nizhny Novgorod Regional Clinical Oncological Dispensary
🇷🇺Nizhny Novgorod, Russian Federation
A.S. Loginov Moscow Clinical Scientific Center
🇷🇺Moscow, Russian Federation
Petrov National Medical Research Center of Oncology
🇷🇺Saint Petersburg, Russian Federation
P.Herzen Moscow Oncological Research Institute
🇷🇺Moscow, Russian Federation
Petrovsky National Research Centre of Surgery
🇷🇺Moscow, Russian Federation
Vishnevsky National Medical Research Center of Surgery
🇷🇺Moscow, Russian Federation