Esophagectomy in Patients With Liver Cirrhosis

Completed

• Conditions: Liver Cirrhosis; Esophageal Cancer
• Interventions: Procedure: surgery

• Registration Number: NCT04809870
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-03-18
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Completion: 2021-04-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-21
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LC (liver cirrhotic patients)	surgery	Patients with concomitant liver cirrhosis
Non-LC (non liver cirrhotic patients)	surgery	Patients without concomitant liver cirrhosis

Primary Outcome Measures

Name	Time	Method
Long-term survival	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Hamburg Medical Institutions; 🇩🇪 Hamburg, Germany