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OpenTrials
Completed

NCT Number: NCT04809870

Esophagectomy in Patients With Liver Cirrhosis

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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Fibrosis Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Liver Cirrhosis Liver Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Hamburg Medical Institutions

Hamburg, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

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

Primary outcomes

  1. Long-term survival

    Time frame: 5 years

Secondary outcomes

  1. Major complication

    Time frame: 90 days postoperatively

    Clavin Dindo ≥ 3

  2. Anastomotic leakage rate

    Time frame: 90 days postoperatively

    Rate of endoscopically diagnosed anastomotic leakage

  3. Sepsis rate

    Time frame: 90 days postoperatively

    Rate of participants with ≥ 2 points in Sepsis-related organ failure (SOFA) score within hospital stay

  4. Renal failure rate

    Time frame: 90 days postoperatively

    Rate of acute kidney insufficiency (AKI) II-III (AKI Kidney Disease: Improving Global Outcomes (KDIGO) Guidelines)

  5. Hepatic failure rate

    Time frame: 90 days postoperatively

    Number of participants with clinical diagnosis: coagulopathy, icterus and potentially hepatic encephalopathy

  6. Cardiac complication

    Time frame: 90 days postoperatively

    cardiac complication requiring pharmacological treatment or intervention and / or ICU surveillance

  7. Chylus fistula rate

    Time frame: 90 days postoperatively

    Concentration of triglycerides (TG) in drain fluids ≥ 3 times TGs i.s.

  8. Pulmonary complications

    Time frame: 90 days postoperatively

    Pneumonia requiring antibiotics, ventilatory insufficiency requiring supportive therapy

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Esophagectomy in Patients With Liver Cirrhosis - an Observational Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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