Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery

Esophageal Cancer Clinical Trial

— ESOSTAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277921
• Other study ID #: 110-2
• Status: Not yet recruiting
• Start date: March 18, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: P. Herzen Moscow Oncology Research Institute
• Contact: Andrey Ryabov, MD, PhD
• Phone: +7 (495) 150-11-22
• Email: ryabovdoc[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: September 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Elective Surgery for gastric cancer
Resection of the esophagus and the gastroesophageal junction via open, laparoscopic or robotic approach

Locations

Country	Name	City	State
Russian Federation	A.S. Loginov Moscow Clinical Scientific Center	Moscow
Russian Federation	I.M. Sechenov First Moscow State Medical University	Moscow
Russian Federation	P.Herzen Moscow Oncological Research Institute	Moscow
Russian Federation	Petrovsky National Research Centre of Surgery	Moscow
Russian Federation	Vishnevsky National Medical Research Center of Surgery	Moscow
Russian Federation	Nizhny Novgorod Regional Clinical Oncological Dispensary	Nizhny Novgorod
Russian Federation	A.Tsyb Medical Radiological Research Centre	Obninsk
Russian Federation	National Medical Research Centre for Oncology	Rostov-on-Don
Russian Federation	Petrov National Medical Research Center of Oncology	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
P. Herzen Moscow Oncology Research Institute	National Medical Research Radiological Centre of the Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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