Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Esophagetomy and Total Gastrectomy Due to Neoplasia

NCT05723783 | Completed

• 1 other identifier: BarretosCH
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the degree of sarcopenia by CT and to analyze its association with morbidity and mortality after esophagectomy and / or total gastrectomy. It is also intended to analyze the association between the degree of the CT-guided sarcopenia and the nutritional status of the patients evaluated by clinical parameters, both preoperative and postoperative. Besides that, to verify the association between the degree of sarcopenia and body fat rate.

Conditions

Sarcopenia; Malnutrition; Gastrostomy; Esophagostomy Complication; Computed Tomography

Keywords

sarcopenia; cancer; gastrectomy; esophagectomy; computed tomography; morbidity; mortality; malnutrition

Outcome Measures

Primary Outcomes (2)

• Degree of sarcopenia

  To assess skeletal muscle mass, areas of interest were considered those between -29 to +150 Hounsfield Units (HU), and converted to cm². The final value obtained was the skeletal muscle mass index (cm²/m²) (MMI), calculated by dividing the value obtained by height (m) squared and classified according to the cut-off points established.

  Preoperative - around 30 days before surgery

• Morbidity and mortality

  Number of complications according to the scale of clavien-dindo after esophagectomy and / or total gastrectomy

  Postoperative - 30 days after surgery

Secondary Outcomes (3)

• Nutritional status

  Preoperative, days 30, 60 and 90 postoperative

• Evolution of serum dosage of hemoglobin albumin and transferrin

  Preoperative, days 30, 60 and 90 postoperative

• Total, visceral and subcutaneous fat area by CT

  preoperative around 30 days before surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Barretos Cancer Hospital with primary esophageal or gastric cancer, undergoing surgical treatment on this institution.

You may qualify if:

• elective esophagectomy and / or total gastrectomy due to neoplasia,
• received oral or enteral diet in less than 48 hours postoperatively. For those who started with an enteral catheter, will be included in the study those with oral feedback up to 7 days.

You may not qualify if:

• Need for colonic transposition instead of gastric tube for reconstruction;
• Presence of any adverse events related to the anesthetic act or not related to the surgical act.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Sarcopenia; Malnutrition; Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Raphael LC Araújo, PHD

  Cancer Hospital Barretos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: February 13, 2023
• Study Start: January 20, 2017
• Primary Completion: December 20, 2018
• Study Completion: January 20, 2019
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

BR (1)