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Esophagectomy in Patients With Liver Cirrhosis

Esophagectomy in Patients With Liver Cirrhosis - an Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04809870
Enrollment
170
Registered
2021-03-22
Start date
2020-10-01
Completion date
2021-04-10
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Liver Cirrhosis

Keywords

esophagectomy

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.

Interventions

PROCEDUREsurgery

retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Long-term survival5 years

Secondary

MeasureTime frameDescription
Anastomotic leakage rate90 days postoperativelyRate of endoscopically diagnosed anastomotic leakage
Sepsis rate90 days postoperativelyRate of participants with ≥ 2 points in Sepsis-related organ failure (SOFA) score within hospital stay
Renal failure rate90 days postoperativelyRate of acute kidney insufficiency (AKI) II-III (AKI Kidney Disease: Improving Global Outcomes (KDIGO) Guidelines)
Major complication90 days postoperativelyClavin Dindo ≥ 3
Cardiac complication90 days postoperativelycardiac complication requiring pharmacological treatment or intervention and / or ICU surveillance
Chylus fistula rate90 days postoperativelyConcentration of triglycerides (TG) in drain fluids ≥ 3 times TGs i.s.
Pulmonary complications90 days postoperativelyPneumonia requiring antibiotics, ventilatory insufficiency requiring supportive therapy
Hepatic failure rate90 days postoperativelyNumber of participants with clinical diagnosis: coagulopathy, icterus and potentially hepatic encephalopathy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026