Age and Gender Corrected Body Mass Index

October 7, 2013 updated by: Johnny Moons, University Hospital, Gasthuisberg

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

650

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

      • Leuven, Belgium, 3000
        • Univresity Hospital Leuven - dept. Thoracic Surgery

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Esophageal cancer patients recieving an esophagectomy

Description

Inclusion Criteria:

  • any type of esophagectomy

Exclusion Criteria:

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

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
AG-BMI < 10 pct
Patients who's peroperative BMI is less than the 10th centile
AG-BMI >= 10th pct
Patients who's peroperative BMI equals or is greater than the 10th centile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall 5 year survival
Time Frame: 5 years after esophagectomy
Overall 5-year survival after esophagectomy for cancer
5 years after esophagectomy

Collaborators and Investigators

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

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

July 1, 2013

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • AG-BMI

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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