Esophagectomy in Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Retrospective and confounder adjusted comparison of perioperative and longterm outcomes of patients requiring an esophagectomy for esophageal cancer with and without concomitant liver cirrhosis.

Official Title
-----------------
Esophagectomy in Patients With Liver Cirrhosis - an Observational Study

Conditions
-----------------
Esophageal Cancer, Liver Cirrhosis

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years primary esophageal cancer with indication for curative treatment follow up period ≥ 5 years LC cohort: pre- or intraoperative histological proof of liver cirrhosis Exclusion Criteria: recurrent esophageal cancer missing indication for curative treatment of esophageal cancer esophagectomy for benign esophageal lesions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LC (liver cirrhotic patients)<br>Patients with concomitant liver cirrhosis | Procedure: surgery<br>* retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis<br>|
| Non-LC (non liver cirrhotic patients)<br>Patients without concomitant liver cirrhosis | Procedure: surgery<br>* retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complication | Clavin Dindo ≥ 3 | 90 days postoperatively | 
| Anastomotic leakage rate | Rate of endoscopically diagnosed anastomotic leakage | 90 days postoperatively | 
| Sepsis rate | Rate of participants with ≥ 2 points in Sepsis-related organ failure (SOFA) score within hospital stay | 90 days postoperatively | 
| Renal failure rate | Rate of acute kidney insufficiency (AKI) II-III (AKI Kidney Disease: Improving Global Outcomes (KDIGO) Guidelines) | 90 days postoperatively | 
| Hepatic failure rate | Number of participants with clinical diagnosis: coagulopathy, icterus and potentially hepatic encephalopathy | 90 days postoperatively | 
| Cardiac complication | cardiac complication requiring pharmacological treatment or intervention and / or ICU surveillance | 90 days postoperatively | 
| Chylus fistula rate | Concentration of triglycerides (TG) in drain fluids ≥ 3 times TGs i.s. | 90 days postoperatively | 
| Pulmonary complications | Pneumonia requiring antibiotics, ventilatory insufficiency requiring supportive therapy | 90 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagectomy