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Clinical Trials/NCT01958697
NCT01958697UnknownNot Applicable

Age and Gender Corrected Body Mass Index: When Preoperative Weight Loss and Underweight Are Becomming Clinically Significant in Esophagectomy for Cancer.

University Hospital, Gasthuisberg1 site in 1 country650 target enrollmentStarted: July 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
650
Locations
1
Primary Endpoint
Overall 5 year survival

Study Overview

Brief Summary

Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body Mass Index (BMI) values are age-independent and the same for both sexes. From the perspective that these two parameters should actually be taken into account too, we developed a model to calculate "age-gender specific BMI-percentiles" (AG-BMI) and tested this model in relation to survival outcome after esophagectomy for cancer.

Detailed Description

Age-Gender specific BMI percentiles are more accurate compared to the current BMI classes in predicting Overall Survival (OS) after esophagectomy for cancer. Furthermore we believe in a more devastating impact on OS from underweight and not from overweight.

By preoperatively identifying risk patients for poorer OS, especially the non-tumoral deaths, this can be a tool to tailor postoperative nutritional strategies to counter further weight loss and bringing postoperative weight to normal ranges.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • any type of esophagectomy

Exclusion Criteria

  • Preoperative organ metastasis (cM+ or yM+)
  • esophageal bypass surgery

Outcomes

Primary Outcomes

Overall 5 year survival

Time Frame: 5 years after esophagectomy

Overall 5-year survival after esophagectomy for cancer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Gasthuisberg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Johnny Moons

Datamanager Thoracic Surgery

University Hospital, Gasthuisberg

Study Sites (1)

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