Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery

NCT ID: NCT06277921

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-18

Study Completion Date

2025-01-20

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with morbidity and mortality

Patients who suffered from any type of morbidity after surgery

Elective Surgery for gastric cancer

Intervention Type PROCEDURE

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

Patients without morbidity and mortality

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

Elective Surgery for gastric cancer

Intervention Type PROCEDURE

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

Interventions

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Elective Surgery for gastric cancer

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

Intervention Type PROCEDURE

Other Intervention Names

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Esophageal or Esophagogastric Junction Cancer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

P. Herzen Moscow Oncology Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Andrey Ryabov

Head of Department of Thoracoabdominal Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrey Ryabov, MD, PhD

Role: STUDY_DIRECTOR

P.Herzen Moscow Oncological Research Institute

Vladimir Khomyakov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Nuriddin Abdulkhakimov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Pavel Smirnov

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Locations

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N.Alexandrov National Cancer Centre of Belarus

Minsk, , Belarus

Site Status

Bryansk Regional Oncological Hospital

Bryansk, , Russia

Site Status

Cheboksary Republican Clinical Oncology Dispensary

Cheboksary, , Russia

Site Status

M.Sigal Republican Medical Oncology Dispensary

Kazan', , Russia

Site Status

A.Loginov Moscow Clinical Scientific Center

Moscow, , Russia

Site Status

Moscow City Oncology Hospital № 62

Moscow, , Russia

Site Status

P.Herzen Moscow Oncological Research Institute

Moscow, , Russia

Site Status

S.Yudin Moscow Oncological Center No.1

Moscow, , Russia

Site Status

University Clinical Hospital №1 of Sechenov University

Moscow, , Russia

Site Status

University Clinical Hospital №4 of Sechenov University

Moscow, , Russia

Site Status

Vishnevsky National Medical Research Center of Surgery

Moscow, , Russia

Site Status

Nizhny Novgorod Regional Clinical Oncological Dispensary

Nizhny Novgorod, , Russia

Site Status

Novosibirsk Regional Clinical Oncology Dispensary

Novosibirsk, , Russia

Site Status

A.Tsyb Medical Radiological Research Centre

Obninsk, , Russia

Site Status

Rostov-on-Don National Medical Research Centre for Oncology

Rostov-on-Don, , Russia

Site Status

Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

Site Status

Saratov Regional Clinical Oncological Dispensary

Saratov, , Russia

Site Status

Ufa Republican Clinical Oncology Dispensary

Ufa, , Russia

Site Status

Countries

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Belarus Russia

Other Identifiers

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110-2

Identifier Type: -

Identifier Source: org_study_id

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