Evolution of Corporeal Composition in the PeriOperative Period

Lung Cancer Clinical Trial

— ECCOP  

Official title:

Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143869
• Other study ID #: 2013-A01346-39
• Status: Completed
• Start date: December 2013
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: September 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)

• Or Lung cancer

• And planned surgical resection

• Age > 18 years

Exclusion Criteria:

• Surgical procedure planned < 48 h

• Pregnancy

• Presence of a cardiac stimulator

Related Conditions & MeSH terms

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

Intervention

Device:
• Bioelectrical Impedance Analysis
Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.

Locations

Country	Name	City	State
France	Hôpital Européen Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	nutritional intake during perioperative period	One of the secondary objective is to investigate the relationship between change in body composition and perioperative nutritional intake.	1 month
Other	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.	6 months
Other	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.	6 months
Primary	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.	1 month
Secondary	perioperative complications	One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.	6 months