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Postoperative Morbidity and Mortality After Gastric Cancer Surgery (GASTROSTAT)

P

P. Herzen Moscow Oncology Research Institute

Status

Not yet enrolling

Conditions

Gastric Cancer
Stomach Cancer
Siewert Type III Adenocarcinoma of Esophagogastric Junction

Treatments

Procedure: Elective Surgery for gastric cancer

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

700 participants in 2 patient groups

Patients with morbidity
Description:
Patients who suffered from any type of morbidity after surgery
Treatment:
Procedure: Elective Surgery for gastric cancer
Patients without morbidity
Description:
Patients who did not suffer from any type of morbidity after surgery
Treatment:
Procedure: Elective Surgery for gastric cancer

Trial contacts and locations

9

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Central trial contact

Andrey Ryabov, MD, PhD

Data sourced from clinicaltrials.gov

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