Postoperative Morbidity and Mortality After Gastric Cancer Surgery

NCT ID: NCT06277908

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2024-12-31

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.

Conditions

Gastric Cancer; Siewert Type III Adenocarcinoma of Esophagogastric Junction; Stomach Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with morbidity

Patients who suffered from any type of morbidity after surgery

Elective Surgery for gastric cancer

Intervention Type: PROCEDURE

Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach

Patients without morbidity

Patients who did not suffer from any type of morbidity after surgery

Elective Surgery for gastric cancer

Intervention Type: PROCEDURE

Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach

Interventions

Elective Surgery for gastric cancer

Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Radiological Centre of the Ministry of Health of Russia

OTHER

Sponsor Role: collaborator

P. Herzen Moscow Oncology Research Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Andrey Ryabov

Head of Department of Thoracoabdominal Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrey Ryabov, MD, PhD

Role: STUDY_DIRECTOR

P.Herzen Moscow Oncological Research Institute

Vladimir Khomyakov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Nuriddin Abdulkhakimov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Pavel Smirnov

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Locations

A.S. Loginov Moscow Clinical Scientific Center

Moscow, , Russia

A.Tsyb Medical Radiological Research Centre

Moscow, , Russia

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

P.Herzen Moscow Oncological Research Institute

Moscow, , Russia

Petrovsky National Research Centre of Surgery

Moscow, , Russia

Vishnevsky National Medical Research Center of Surgery

Moscow, , Russia

Nizhny Novgorod Regional Clinical Oncological Dispensary

Nizhny Novgorod, , Russia

National Medical Research Centre for Oncology

Rostov-on-Don, , Russia

Petrov National Medical Research Center of Oncology

Saint Petersburg, , Russia

Countries

Russia

Central Contacts

Andrey Ryabov, MD, PhD

Role: CONTACT

ryabovdoc@mail.ru

+7 (495) 150-11-22

Facility Contacts

Roman Izrailov

Role: primary

Nikolay Semenov

Role: backup

Andrey Ryabov

Role: primary

Nuriddin Abdulkhakimov

Role: backup

Other Identifiers

110-1

Identifier Type: -

Identifier Source: org_study_id