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CompletedNCT02143869ECCOPUpdated Sep 4, 2019

Evolution of Corporeal Composition in the PeriOperative Period

An observational study in Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal) and Lung Cancer, sponsored by Hôpital Européen Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by Hôpital Européen Marseille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
374
Ages
18 Years and older
Sex
All
01

Study summary

Denutrition and Obesity are risk factors for perioperative surgical complications.

In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.

In this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).

Read the detailed description

Body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery.

Others data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and CT-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.

02

Conditions studied

  • Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal)
  • Lung Cancer

Keywords

  • Gastrointestinal cancer
  • Lung cancer
  • Bioelectrical Impedance analysis
  • Body composition
  • Perioperative
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 374 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hôpital Européen Marseille is the lead sponsor of 30 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal) or lung cancer undergoing curative surgical resection as part of their disease management.

Inclusion criteria

  • Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)
  • Or Lung cancer
  • And planned surgical resection
  • Age > 18 years

Exclusion criteria

Exclusion Criteria:

  • Surgical procedure planned \< 48 h
  • Pregnancy
  • Presence of a cardiac stimulator
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
374 participants (actual)
Patient registry
No

Interventions

  • DeviceBioelectrical Impedance Analysis

    Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.

06

What researchers measure

Primary outcomes

  1. body composition

    The primary objective is to study the change in body composition (fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water) during the perioperative period with respect to short, mid and long term outcome.

    Time frame: 1 month

Secondary outcomes

  1. perioperative complications

    One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.

    Time frame: 6 months

Other outcomes

  1. nutritional intake during perioperative period

    One of the secondary objective is to investigate the relationship between change in body composition and perioperative nutritional intake.

    Time frame: 1 month

  2. cancer type and stage

    One of the secondary objective is to investigate the relationship between baseline body composition and the type and stage of cancer.

    Time frame: 6 months

  3. comparison of the body composition obtained by BIA and anthropometric measurements.

    One of the secondary objective is to compare the body composition obtained by Bioelectrical Impedance Analysis (BIA) and by anthropometric measurements.

    Time frame: 6 months

07

Study locations

1 site
  • Hôpital Européen Marseille
    Marseille, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02143869
Lead sponsor
Hôpital Européen Marseille
Responsible party
Jerome Allardet-Servent, MD (MD, MSc, Hôpital Européen Marseille) — Principal investigator
First posted
May 21, 2014
Start date
Dec 2013
Primary completion
Dec 2016
Completion
Sep 2019
Last update
Sep 4, 2019

Study contacts

Jérôme ALLARDET-SERVENT, MD, MSc
principal investigator · Hôpital Européen Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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