Postoperative Morbidity and Mortality After Gastric Cancer Surgery

NCT06277908 | Not Yet Recruiting

• 1 other identifier: 110-1
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Gastric cancer; Surgery; Morbidity; Mortality

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with morbidity

Patients who suffered from any type of morbidity after surgery

Procedure: Elective Surgery for gastric cancer

Patients without morbidity

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

Procedure: Elective Surgery for gastric cancer

Interventions

Elective Surgery for gastric cancer PROCEDURE

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

Patients with morbidity; Patients without morbidity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• P. Herzen Moscow Oncology Research Institute: lead
• National Medical Research Radiological Centre of the Ministry of Health of Russia: collaborator

Study Sites (9)

A.S. Loginov Moscow Clinical Scientific Center

Moscow, Russia

Location

A.Tsyb Medical Radiological Research Centre

Moscow, Russia

Location

I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

P.Herzen Moscow Oncological Research Institute

Moscow, Russia

Location

Petrovsky National Research Centre of Surgery

Moscow, Russia

Location

Vishnevsky National Medical Research Center of Surgery

Moscow, Russia

Location

Nizhny Novgorod Regional Clinical Oncological Dispensary

Nizhny Novgorod, Russia

Location

National Medical Research Centre for Oncology

Rostov-on-Don, Russia

Location

Petrov National Medical Research Center of Oncology

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Andrey Ryabov, MD, PhD

  P.Herzen Moscow Oncological Research Institute

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrey Ryabov, MD, PhD

CONTACT

+7 (495) 150-11-22; ryabovdoc@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Thoracoabdominal Oncology

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 26, 2024
• Study Start: March 18, 2024
• Primary Completion: September 18, 2024
• Study Completion: December 31, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

RU (9)