Postoperative Morbidity and Mortality After Gastric Cancer Surgery (GASTROSTAT)

February 18, 2024 updated by: Andrey Ryabov, P. Herzen Moscow Oncology Research Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrey Ryabov, MD, PhD
  • Phone Number: +7 (495) 150-11-22
  • Email: ryabovdoc@mail.ru

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • I.M. Sechenov First Moscow State Medical University
      • Moscow, Russian Federation
        • A.S. Loginov Moscow Clinical Scientific Center
        • Contact:
          • Roman Izrailov
        • Contact:
          • Nikolay Semenov
      • Moscow, Russian Federation
        • A.Tsyb Medical Radiological Research Centre
      • Moscow, Russian Federation
        • P.Herzen Moscow Oncological Research Institute
        • Contact:
          • Andrey Ryabov
        • Contact:
          • Nuriddin Abdulkhakimov
      • Moscow, Russian Federation
        • Petrovsky National Research Centre of Surgery
      • Moscow, Russian Federation
        • Vishnevsky National Medical Research Center of Surgery
      • Nizhny Novgorod, Russian Federation
        • Nizhny Novgorod Regional Clinical Oncological Dispensary
      • Rostov-on-Don, Russian Federation
        • National Medical Research Centre for Oncology
      • Saint Petersburg, Russian Federation
        • Petrov National Medical Research Center of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with morbidity
Patients who suffered from any type of morbidity after surgery
Procedure: Elective Surgery for gastric cancer
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
Procedure: Elective Surgery for gastric cancer
Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the type of complications and the incidence of it
Time Frame: 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.
within 90 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

P. Herzen Moscow Oncology Research Institute

Collaborators

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

Investigators

  • Study Director: Andrey Ryabov, MD, PhD, P.Herzen Moscow Oncological Research Institute
  • Principal Investigator: Vladimir Khomyakov, MD, PhD, P.Herzen Moscow Oncological Research Institute
  • Principal Investigator: Nuriddin Abdulkhakimov, MD, PhD, P.Herzen Moscow Oncological Research Institute
  • Principal Investigator: Pavel Smirnov, P.Herzen Moscow Oncological Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 18, 2024

Primary Completion (Estimated)

September 18, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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