Cancer of StomachNCT05088304
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
An observational study of Cancer of Stomach and Cancer of Esophagus, run by Jinling Hospital, China.
Trial summary
The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Stomach, Cancer of Esophagus, Malnutrition
- How many people
- 205 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)
Who may be able to join
- Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.
Who cannot join
- Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin>3mg/dL) ; Renal insufficiency (serum creatinine>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.
About this study
Official title: The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.
Read the detailed description
The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.
Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.
- Conditions
- Cancer of Stomach, Cancer of Esophagus, Malnutrition, Muscle Loss
- Being tested
- no intervention
- Keywords
- FFIM, GLIM, Cancer, Postoperative complications
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Malnutrition, Muscular Atrophy, Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| The normal FFMI group | The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, </≥15 kg/m2 for females and </≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female). Receives: Other: no intervention | |
| The low FFMI group | The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, </≥15 kg/m2 for females and </≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI <17 kg/m2 for male and FFMI <15 kg/m2 for female). Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
postoperative complications (infectious complications and noninfectious complications)
Measured: Within 60 days after surgery
Secondary outcomes (5)
length of stay (LOS)
length of stay (LOS)
Measured: Within 60 days after surgery
wound healing time
wound healing time
Measured: Within 60 days after surgery
postoperative antibiotic time
postoperative antibiotic time
Measured: Within 60 days after surgery
nutritional status
nutritional status ( such as: weight，albumin，prealbumin)
Measured: up to 4 weeks
hospitalization cost
hospitalization cost(including: surgery and medicine costs)
Measured: Within 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Sep 2015
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of StomachStudies 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
- Retrospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, Subei People's Hospital of Jiangsu Province, Peking Union Medical College
- Responsible party
- Principal investigator, Wang Xinying, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088304
- Sponsor's protocol ID
- JinlingHospital-1
- Other IDs
- 201502022
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
- ClinicalTrials.gov ID
- NCT05088304
- Acronym / sponsor ID
- JinlingHospital-1
- Conditions
- Cancer of Stomach, Cancer of Esophagus, Malnutrition, Muscle Loss
- Keywords
- FFIM, GLIM, Cancer, Postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, Subei People's Hospital of Jiangsu Province, Peking Union Medical College
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 21 Oct 2021 (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 present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.
Detailed description
The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.
Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The normal FFMI group | – | Other: no interventionThe FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, </≥15 kg/m2 for females and </≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female). |
| The low FFMI group | – | Other: no interventionThe FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, </≥15 kg/m2 for females and </≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI <17 kg/m2 for male and FFMI <15 kg/m2 for female). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)
Key inclusion criteria (1 listed)
- Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.
Key exclusion criteria (1 listed)
- Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin>3mg/dL) ; Renal insufficiency (serum creatinine>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | The low FFMI group, The normal FFMI group |
Primary outcome
postoperative complications
Time frame: Within 60 days after surgery
postoperative complications (infectious complications and noninfectious complications)
5 secondary outcomes
length of stay (LOS)
Time frame: Within 60 days after surgery
wound healing time
Time frame: Within 60 days after surgery
postoperative antibiotic time
Time frame: Within 60 days after surgery
nutritional status
Time frame: up to 4 weeks
hospitalization cost
Time frame: Within 60 days after 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 21 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Stomach and Cancer of Esophagus, run by Jinling Hospital, China.
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 1 inclusion and 1 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
postoperative complications (time frame: Within 60 days after surgery). 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 21 Oct 2021.