Postoperative Morbidity and Mortality After Gastric Cancer Surgery

Gastric Cancer Clinical Trial

— GASTROSTAT  

Official title:

90-day Postoperative Morbidity and Mortality After Elective Surgery for Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277908
• Other study ID #: 110-1
• Status: Not yet recruiting
• Start date: March 18, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: P. Herzen Moscow Oncology Research Institute
• Contact: Andrey Ryabov, MD, PhD
• Phone: +7 (495) 150-11-22
• Email: ryabovdoc[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 31, 2024
• Est. primary completion date: September 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Siewert Type III Adenocarcinoma of Esophagogastric Junction
• Stomach Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Elective Surgery for gastric cancer
Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach

Locations

Country	Name	City	State
Russian Federation	A.S. Loginov Moscow Clinical Scientific Center	Moscow
Russian Federation	A.Tsyb Medical Radiological Research Centre	Moscow
Russian Federation	I.M. Sechenov First Moscow State Medical University	Moscow
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	Nizhny Novgorod Regional Clinical Oncological Dispensary	Nizhny Novgorod
Russian Federation	National Medical Research Centre for Oncology	Rostov-on-Don
Russian Federation	Petrov National Medical Research Center of Oncology	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
P. Herzen Moscow Oncology Research Institute	National Medical Research Radiological Centre of the Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 90 days after operation