Clinical trial NCT05723783: Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Esophagetomy and Total Gastrectomy Due to Neoplasia
Official title: The Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Patients Submitted to Esophagetomy and Total Gastrectomy Due to Neoplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Malnutrition
Gastrostomy
Esophagostomy Complication
Computed Tomography
Keywords: sarcopenia
cancer
gastrectomy
esophagectomy
computed tomography
morbidity
mortality
malnutrition
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Barretos Cancer Hospital with primary esophageal or gastric cancer, undergoing surgical treatment on this institution.

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.

Detailed description: Background: Malnutrition is highly prevalent in patients with esophageal and / or stomach cancer, and is often followed by sarcopenia (loss of muscle mass and strength). Both syndromes influence negatively on prognosis of oncological patients, by increasing hospitalization time, number of complications and hospital expenses. Therefore, it is extremely important to identify patients at nutritional risk. This nutritional assessment can be done through clinical and laboratory tests, as well as can be inferred through computed tomography (CT) imaging.

Hypothesis: To evaluate the relationship between the rate of CT-guided sarcopenia and the surgery outcomes of patients undergoing esophagectomy and / or total gastrectomy due to neoplasia.

Methods: Prospective non-randomized study evaluating the nutritional status and morbidity and mortality of patients. The cases will be conducted according to a pre-established protocol and the sample, for convenience, will be 80 patients. Demographic data and information on diagnosis, treatment and post-surgical data will be collected, as well as anthropometric evaluation. In addition, biochemical data such as hemoglobin, transferrin and serum albumin values will be assessed to classify the patient's nutritional status. The CT images will be analyzed in order to evaluate the degree of sarcopenia and body fat rate, using the distal sections of the third lumbar vertebra. In order to evaluate skeletal muscle mass, the areas of interest will be ones between -30 and +110 hounsfield units (HU) and for the analysis of visceral fat area analysis, pixels with densities between -190 to -30 HU will be used. Both results will be converted to cm2 and analyzed through pre-set cutoff values.

Statistical analysis: Descriptive analyzes will be performed using Fisher's exact tests, for proportions; Wilkcoxon rank-sum test for analyzes of continuous and non-parametric variables. Univariate analyzes will be performed to compare the variables of interest of the study, with the other variables. All tests will have a 5% significance level.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Degree of sarcopenia
timeFrame: Preoperative - around 30 days before surgery
measure: Morbidity and mortality
timeFrame: Postoperative - 30 days after surgery
Secondary outcomes:
measure: Nutritional status
timeFrame: Preoperative, days 30, 60 and 90 postoperative
measure: Evolution of serum dosage of hemoglobin albumin and transferrin
timeFrame: Preoperative, days 30, 60 and 90 postoperative
measure: Total, visceral and subcutaneous fat area by CT
timeFrame: preoperative around 30 days before surgery
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
affiliation: Cancer Hospital Barretos
name: Raphael LC Araújo, PHD
role: PRINCIPAL_INVESTIGATOR
References: