Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery

Not yet recruiting

• Conditions: Siewert Type I Adenocarcinoma of Esophagogastric Junction; Esophageal Cancer; Oesophageal Cancer; Siewert Type III Adenocarcinoma of Esophagogastric Junction
• Interventions: Procedure: Elective Surgery for gastric cancer

• Registration Number: NCT06277921
• Lead Sponsor: P. Herzen Moscow Oncology Research Institute

Brief Summary

Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.

However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Detailed Description

Esophageal and esophago-gastric junction cancer is the seventh most common malignancy and the sixth leading cause of cancer-related mortality worldwide.

Surgery remains the primary treatment for esophageal cancer and is one of the most technically challenging interventions in oncological surgery. In addition, esophagectomy is associated with high risks of postoperative complications, with rates varying from clinic to clinic. Esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively.

The problem with the available studies of the course of the postoperative period is the significant heterogeneity of research methods, which does not allow us to obtain a true picture of the results of surgical treatment of the esophagus and esophagogastric junction cancer in the Russian Federation.

To improve the quality of further studies and recommendations on standardization of surgical treatment of esophageal and esophagogastric junction cancer and its morbidity, there is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Study Start: 2024-03-18
• Primary Completion: 2024-09-18
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• All consecutive patients with clinically documented primary Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - 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 a previous staging laparoscopy, or those with known synchronous other cancers.
• Esophagogastric Junction Siewert III malignancy
• Patients submitted to Emergency surgery or surgery without curative intent
• Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with morbidity and mortality	Elective Surgery for gastric cancer	Patients who suffered from any type of morbidity after surgery
Patients without morbidity and mortality	Elective Surgery for gastric cancer	Patients who did not suffer from any type of morbidity after surgery

Primary Outcome Measures

Name	Time	Method
the type of complications and the incidence of it	within 90 days after operation	the types of complication is classified into as follows: gastrointestinal (anastomotic leak, conduit necrosis/failure, pancreatitis, GI Bleeding, delayed conduit emptying); pulmonary (pneumonia, pleural effusion, pneumothorax, respiratory failure, ARDS, acute aspiration, tracheobronchial Injury); cardiac; thromboembolic; urologic; infection (wound infection; intrathoracic/intra-abdominal abscess; generalized sepsis; other infections); neurologic (recurrent nerve injury, acute delirium) and other (thoracic wound dehiscence, diaphragmatic hernia, chyle leak, reoperation other than for anastomotic leak or conduit necrosis, multiple organ dysfunction syndrome) complications Each complication will be graded according to Clavien-Dindo classification. Re-admission or visiting emergency room will be checked and recorded.

Trial Locations

Locations (9)

Petrovsky National Research Centre of Surgery; 🇷🇺 Moscow, Russian Federation

A.S. Loginov Moscow Clinical Scientific Center; 🇷🇺 Moscow, Russian Federation

I.M. Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation

P.Herzen Moscow Oncological Research Institute; 🇷🇺 Moscow, Russian Federation

Vishnevsky National Medical Research Center of Surgery; 🇷🇺 Moscow, Russian Federation

A.Tsyb Medical Radiological Research Centre; 🇷🇺 Obninsk, 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, Russian Federation