Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery

NCT06277921 | Completed

• 1 other identifier: 110-2
• Study Type: observational
• Target: 230
• Locations: 2 countries
• Sites: 18

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.

Conditions

Esophageal Cancer; Oesophageal Cancer; Siewert Type I Adenocarcinoma of Esophagogastric Junction; Siewert Type III Adenocarcinoma of Esophagogastric Junction

Keywords

Esophageal Cancer; Esophagogastric Junction Cancer; Morbidity; Mortality; Surgery

Outcome Measures

Primary Outcomes (1)

• the type of complications and the incidence of it

  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.

  within 90 days after operation

Study Arms (2)

Patients with morbidity and mortality

Patients who suffered from any type of morbidity after surgery

Procedure: Elective Surgery for gastric cancer

Patients without morbidity and mortality

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

Resection of the esophagus and the gastroesophageal junction via open, laparoscopic or robotic approach

Also known as: Esophageal or Esophagogastric Junction Cancer

Patients with morbidity and mortality; Patients without morbidity and mortality

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 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (18)

N.Alexandrov National Cancer Centre of Belarus

Minsk, Belarus

Location

Bryansk Regional Oncological Hospital

Bryansk, Russia

Location

Cheboksary Republican Clinical Oncology Dispensary

Cheboksary, Russia

Location

M.Sigal Republican Medical Oncology Dispensary

Kazan', Russia

Location

A.Loginov Moscow Clinical Scientific Center

Moscow, Russia

Location

Moscow City Oncology Hospital № 62

Moscow, Russia

Location

P.Herzen Moscow Oncological Research Institute

Moscow, Russia

Location

S.Yudin Moscow Oncological Center No.1

Moscow, Russia

Location

University Clinical Hospital №1 of Sechenov University

Moscow, Russia

Location

University Clinical Hospital №4 of Sechenov University

Moscow, Russia

Location

Vishnevsky National Medical Research Center of Surgery

Moscow, Russia

Location

Nizhny Novgorod Regional Clinical Oncological Dispensary

Nizhny Novgorod, Russia

Location

Novosibirsk Regional Clinical Oncology Dispensary

Novosibirsk, Russia

Location

A.Tsyb Medical Radiological Research Centre

Obninsk, Russia

Location

Rostov-on-Don National Medical Research Centre for Oncology

Rostov-on-Don, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Location

Saratov Regional Clinical Oncological Dispensary

Saratov, Russia

Location

Ufa Republican Clinical Oncology Dispensary

Ufa, Russia

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal 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

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: January 20, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

BE (1); RU (17)