SarcopeniaNCT05723783
Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Esophagetomy and Total Gastrectomy Due to Neoplasia
An observational study of Sarcopenia and Malnutrition, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcopenia, Malnutrition, Gastrostomy
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2017to 20 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients of Barretos Cancer Hospital with primary esophageal or gastric cancer, undergoing surgical treatment on this institution.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Patients Submitted to Esophagetomy and Total Gastrectomy Due to Neoplasia
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.
Read the 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.
- Keywords
- sarcopenia, cancer, gastrectomy, esophagectomy, computed tomography, morbidity, mortality, malnutrition
- Medical subject headings
- Sarcopenia, Malnutrition, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Postoperative - 30 days after surgery
Secondary outcomes (3)
Nutritional status
Analyze the nutritional status of the patients evaluated by clinical parameters (weight in kilograms and height in meters will be combined to report Body Mass Index in kg/m²).
Measured: Preoperative, days 30, 60 and 90 postoperative
Evolution of serum dosage of hemoglobin albumin and transferrin
Analyze biochemical parameters: serum levels of albumina (g/dL), transferrina (mg/dL) and hemoglobina (g/dL).
Measured: Preoperative, days 30, 60 and 90 postoperative
Total, visceral and subcutaneous fat area by CT
Total fat area (TFA) and visceral fat area (VFA) were evaluated by measuring pixels with densities between -190 to -30 Hounsfield Units in cm². Subcutaneous fat area was calculated from AGT subtraction of AGT.
Measured: preoperative around 30 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Jan 2017
- Primary completion20 Dec 2018
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael LC Araújo, PHD, Principal investigator, Cancer Hospital Barretos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723783
- Sponsor's protocol ID
- BarretosCH
- Status last verified
- Feb 2023
- First submitted
- 21 Aug 2018
- Last updated
- 13 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of CT-guided Sarcopenia for Surgical Outcomes in Patients Submitted to Esophagetomy and Total Gastrectomy Due to Neoplasia
- ClinicalTrials.gov ID
- NCT05723783
- Acronym / sponsor ID
- BarretosCH
- Keywords
- sarcopenia, cancer, gastrectomy, esophagectomy, computed tomography, morbidity, mortality, malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of Barretos Cancer Hospital with primary esophageal or gastric cancer, undergoing surgical treatment on this institution.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of sarcopenia
Time frame: Preoperative - around 30 days before surgery
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.
Morbidity and mortality
Time frame: Postoperative - 30 days after surgery
Number of complications according to the scale of clavien-dindo after esophagectomy and / or total gastrectomy
3 secondary outcomes
Nutritional status
Time frame: Preoperative, days 30, 60 and 90 postoperative
Evolution of serum dosage of hemoglobin albumin and transferrin
Time frame: Preoperative, days 30, 60 and 90 postoperative
Total, visceral and subcutaneous fat area by CT
Time frame: preoperative around 30 days before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael LC Araújo, PHD principal investigator
Cancer Hospital Barretos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Malnutrition, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of sarcopenia (time frame: Preoperative - around 30 days before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.