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Trial Title:
Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery
NCT ID:
NCT06277921
Condition:
Esophageal Cancer
Oesophageal Cancer
Siewert Type I Adenocarcinoma of Esophagogastric Junction
Siewert Type III Adenocarcinoma of Esophagogastric Junction
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Conditions: Keywords:
Esophageal Cancer
Esophagogastric Junction Cancer
Morbidity
Mortality
Surgery
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Elective Surgery for gastric cancer
Description:
Resection of the esophagus and the gastroesophageal junction via open, laparoscopic or
robotic approach
Arm group label:
Patients with morbidity and mortality
Arm group label:
Patients without morbidity and mortality
Other name:
Esophageal or Esophagogastric Junction Cancer
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
A.S. Loginov Moscow Clinical Scientific Center
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
I.M. Sechenov First Moscow State Medical University
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
P.Herzen Moscow Oncological Research Institute
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Andrey Ryabov
Contact backup:
Last name:
Nuriddin Abdulkhakimov
Facility:
Name:
Petrovsky National Research Centre of Surgery
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
Vishnevsky National Medical Research Center of Surgery
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
Nizhny Novgorod Regional Clinical Oncological Dispensary
Address:
City:
Nizhny Novgorod
Country:
Russian Federation
Facility:
Name:
A.Tsyb Medical Radiological Research Centre
Address:
City:
Obninsk
Country:
Russian Federation
Facility:
Name:
National Medical Research Centre for Oncology
Address:
City:
Rostov-on-Don
Country:
Russian Federation
Facility:
Name:
Petrov National Medical Research Center of Oncology
Address:
City:
Saint Petersburg
Country:
Russian Federation
Start date:
March 18, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
P. Herzen Moscow Oncology Research Institute
Agency class:
Other
Collaborator:
Agency:
National Medical Research Radiological Centre of the Ministry of Health of Russia
Agency class:
Other
Source:
P. Herzen Moscow Oncology Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277921
