Esophagectomy in Patients With Liver Cirrhosis

Esophageal Cancer Clinical Trial

Official title:

Esophagectomy in Patients With Liver Cirrhosis - an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809870
• Other study ID #: UKE Hamburg
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: April 10, 2021

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 10, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Fibrosis
• Liver Cirrhosis

Intervention

Procedure:
• surgery
retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis

Locations

Country	Name	City	State
Germany	University of Hamburg Medical Institutions	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term survival		5 years
Secondary	Major complication	Clavin Dindo = 3	90 days postoperatively
Secondary	Anastomotic leakage rate	Rate of endoscopically diagnosed anastomotic leakage	90 days postoperatively
Secondary	Sepsis rate	Rate of participants with = 2 points in Sepsis-related organ failure (SOFA) score within hospital stay	90 days postoperatively
Secondary	Renal failure rate	Rate of acute kidney insufficiency (AKI) II-III (AKI Kidney Disease: Improving Global Outcomes (KDIGO) Guidelines)	90 days postoperatively
Secondary	Hepatic failure rate	Number of participants with clinical diagnosis: coagulopathy, icterus and potentially hepatic encephalopathy	90 days postoperatively
Secondary	Cardiac complication	cardiac complication requiring pharmacological treatment or intervention and / or ICU surveillance	90 days postoperatively
Secondary	Chylus fistula rate	Concentration of triglycerides (TG) in drain fluids = 3 times TGs i.s.	90 days postoperatively
Secondary	Pulmonary complications	Pneumonia requiring antibiotics, ventilatory insufficiency requiring supportive therapy	90 days postoperatively