NCT04809870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

March 18, 2021

Last Update Submit

May 21, 2023

Conditions

Esophageal CancerLiver Cirrhosis

Keywords

esophagectomy

Outcome Measures

Primary Outcomes (1)

  • Long-term survival

    5 years

Secondary Outcomes (8)

  • Major complication

    90 days postoperatively

  • Anastomotic leakage rate

    90 days postoperatively

  • Sepsis rate

    90 days postoperatively

  • Renal failure rate

    90 days postoperatively

  • Hepatic failure rate

    90 days postoperatively

  • +3 more secondary outcomes

Study Arms (2)

LC (liver cirrhotic patients)

Patients with concomitant liver cirrhosis

Procedure: surgery

Non-LC (non liver cirrhotic patients)

Patients without concomitant liver cirrhosis

Procedure: surgery

Interventions

surgeryPROCEDURE

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

LC (liver cirrhotic patients)Non-LC (non liver cirrhotic patients)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • recurrent esophageal cancer
  • missing indication for curative treatment of esophageal cancer
  • esophagectomy for benign esophageal lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hamburg Medical Institutions

Hamburg, Germany

Location

MeSH Terms

Conditions

Esophageal NeoplasmsLiver Cirrhosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesLiver DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Reeh, MD

    1Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 22, 2021

Study Start

October 1, 2020

Primary Completion

March 18, 2021

Study Completion

April 10, 2021

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

DE(1)