Esophagectomy in Patients With Liver Cirrhosis

May 21, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf

Esophagectomy in Patients With Liver Cirrhosis - an Observational Study

Retrospective and confounder adjusted comparison of perioperative and longterm outcomes of patients requiring an esophagectomy for esophageal cancer with and without concomitant liver cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • University of Hamburg Medical Institutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

retrospective analysis of a prospective maintained database of EC patients operated at the institution between 2012 to 2016

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LC (liver cirrhotic patients)
Patients with concomitant liver cirrhosis
Procedure: surgery
retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis
Non-LC (non liver cirrhotic patients)
Patients without concomitant liver cirrhosis
Procedure: surgery
retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Reeh, MD, 1Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

March 18, 2021

Study Completion (Actual)

April 10, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKE Hamburg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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