Clinical trial NCT06277908: Postoperative Morbidity and Mortality After Gastric Cancer Surgery
Official title: 90-day Postoperative Morbidity and Mortality After Elective Surgery for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer
Siewert Type III Adenocarcinoma of Esophagogastric Junction
Stomach Cancer
Keywords: Gastric cancer
Surgery
Morbidity
Mortality
Lead sponsor: P. Herzen Moscow Oncology Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: National Medical Research Radiological Centre of the Ministry of Health of Russia
First posted: 2024-02-26
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility 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.

Primary outcomes:
measure: the type of complications and the incidence of it
timeFrame: within 90 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: A.S. Loginov Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: A.Tsyb Medical Radiological Research Centre
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: P.Herzen Moscow Oncological Research Institute
city: Moscow
country: Russian Federation
facility: Petrovsky National Research Centre of Surgery
city: Moscow
country: Russian Federation
facility: Vishnevsky National Medical Research Center of Surgery
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Oncological Dispensary
city: Rostov-on-Don
country: Russian Federation
facility: National Medical Research Centre for Oncology
city: Saint Petersburg
country: Russian Federation
facility: Petrov National Medical Research Center of Oncology
Study officials:
affiliation: P.Herzen Moscow Oncological Research Institute
name: Andrey Ryabov, MD, PhD
role: STUDY_DIRECTOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Vladimir Khomyakov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Nuriddin Abdulkhakimov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Pavel Smirnov
role: PRINCIPAL_INVESTIGATOR
References: