Esophageal CancerNCT04809870
Esophagectomy in Patients With Liver Cirrhosis
An observational study of Esophageal Cancer and Liver Cirrhosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Liver Cirrhosis
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 10 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: retrospective analysis of a prospective maintained database of EC patients operated at the institution between 2012 to 2016
Who may be able to join
- 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
Who cannot join
- recurrent esophageal cancer
- missing indication for curative treatment of esophageal cancer
- esophagectomy for benign esophageal lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Esophageal Cancer, Liver Cirrhosis
- Being tested
- surgery
- Keywords
- esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis
| Study group | Role | What they receive |
|---|---|---|
| LC (liver cirrhotic patients) | Patients with concomitant liver cirrhosis Receives: Procedure: surgery | |
| Non-LC (non liver cirrhotic patients) | Patients without concomitant liver cirrhosis Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival
Measured: 5 years
Secondary outcomes (8)
Major complication
Clavin Dindo ≥ 3
Measured: 90 days postoperatively
Anastomotic leakage rate
Rate of endoscopically diagnosed anastomotic leakage
Measured: 90 days postoperatively
Sepsis rate
Rate of participants with ≥ 2 points in Sepsis-related organ failure (SOFA) score within hospital stay
Measured: 90 days postoperatively
Renal failure rate
Rate of acute kidney insufficiency (AKI) II-III (AKI Kidney Disease: Improving Global Outcomes (KDIGO) Guidelines)
Measured: 90 days postoperatively
Hepatic failure rate
Number of participants with clinical diagnosis: coagulopathy, icterus and potentially hepatic encephalopathy
Measured: 90 days postoperatively
Cardiac complication
cardiac complication requiring pharmacological treatment or intervention and / or ICU surveillance
Measured: 90 days postoperatively
Chylus fistula rate
Concentration of triglycerides (TG) in drain fluids ≥ 3 times TGs i.s.
Measured: 90 days postoperatively
Pulmonary complications
Pneumonia requiring antibiotics, ventilatory insufficiency requiring supportive therapy
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Oct 2020
- Primary completion18 Mar 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reeh, MD, Principal investigator, 1Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809870
- Sponsor's protocol ID
- UKE Hamburg
- Status last verified
- May 2023
- First submitted
- 18 Mar 2021
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagectomy in Patients With Liver Cirrhosis - an Observational Study
- ClinicalTrials.gov ID
- NCT04809870
- Acronym / sponsor ID
- UKE Hamburg
- Conditions
- Esophageal Cancer, Liver Cirrhosis
- Keywords
- esophagectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC (liver cirrhotic patients) | – | Procedure: surgeryPatients with concomitant liver cirrhosis |
| Non-LC (non liver cirrhotic patients) | – | Procedure: surgeryPatients without concomitant liver cirrhosis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective analysis of a prospective maintained database of EC patients operated at the institution between 2012 to 2016
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- recurrent esophageal cancer
- missing indication for curative treatment of esophageal cancer
- esophagectomy for benign esophageal lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryretrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis | Procedure or surgery | LC (liver cirrhotic patients), Non-LC (non liver cirrhotic patients) |
Primary outcome
Long-term survival
Time frame: 5 years
8 secondary outcomes
Major complication
Time frame: 90 days postoperatively
Anastomotic leakage rate
Time frame: 90 days postoperatively
Sepsis rate
Time frame: 90 days postoperatively
Renal failure rate
Time frame: 90 days postoperatively
Hepatic failure rate
Time frame: 90 days postoperatively
Cardiac complication
Time frame: 90 days postoperatively
Chylus fistula rate
Time frame: 90 days postoperatively
Pulmonary complications
Time frame: 90 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reeh, MD principal investigator
1Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Liver Cirrhosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.