Clinical trial NCT06277921: Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery
Official title: 90-day Postoperative Morbidity and Mortality After Elective Surgery for Esophageal and Esophagogastric Junction Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: P. Herzen Moscow Oncology Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: National Medical Research Radiological Centre of the Ministry of Health of Russia
First posted: 2024-02-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: the type of complications and the incidence of it
timeFrame: within 90 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: A.S. Loginov Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: P.Herzen Moscow Oncological Research Institute
city: Moscow
country: Russian Federation
facility: Petrovsky National Research Centre of Surgery
city: Moscow
country: Russian Federation
facility: Vishnevsky National Medical Research Center of Surgery
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Oncological Dispensary
city: Obninsk
country: Russian Federation
facility: A.Tsyb Medical Radiological Research Centre
city: Rostov-on-Don
country: Russian Federation
facility: National Medical Research Centre for Oncology
city: Saint Petersburg
country: Russian Federation
facility: Petrov National Medical Research Center of Oncology
Study officials:
affiliation: P.Herzen Moscow Oncological Research Institute
name: Andrey Ryabov, MD, PhD
role: STUDY_DIRECTOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Vladimir Khomyakov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Nuriddin Abdulkhakimov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Pavel Smirnov
role: PRINCIPAL_INVESTIGATOR
References: