Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery (ESOSTAT)

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

90-day Postoperative Morbidity and Mortality After Elective Surgery for Esophageal and Esophagogastric Junction Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

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
      • 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
      • Obninsk, Russian Federation
        • A.Tsyb Medical Radiological Research Centre
      • 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 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

Description

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 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 and mortality
Patients who suffered from any type of morbidity after surgery
Procedure: Elective Surgery for gastric cancer
Resection of the esophagus and the gastroesophageal junction via open, laparoscopic or robotic approach
Other Names:
  • Esophageal or Esophagogastric Junction Cancer
Patients without morbidity and mortality
Patients who did not suffer from any type of morbidity after surgery
Procedure: Elective Surgery for gastric cancer
Resection of the esophagus and the gastroesophageal junction via open, laparoscopic or robotic approach
Other Names:
  • Esophageal or Esophagogastric Junction Cancer

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: 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

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 (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

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

  • 110-2

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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