Gastrointestinal MalignanciesNCT07104175
Predictive Value of NRS2002 and GLIM for Complications After GI Malignancy Surgery
An observational study of Gastrointestinal Malignancies, run by Third central hospital of Tianjin affiliated Nankai university at 1 site in China.
Trial summary
This prospective cohort study investigates and compares the predictive power of two nutritional assessment tools, the Nutritional Risk Screening 2002 (NRS2002) and 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
- Gastrointestinal Malignancies
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Jan 2025
- 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: The study population consists of adult patients (≥18 years) with a new, histopathologically confirmed diagnosis of a primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer). These patients were admitted to a single tertiary care center for elective, curative-intent surgical resection between December 2019 and December 2024. The population represents individuals who had not received prior anti-tumor treatments for their current malignancy.
Who may be able to join
- Age ≥ 18 years.
- Histopathologically confirmed primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer).
- Planned curative-intent surgical resection.
- No prior anti-tumor treatments such as surgery, radiotherapy, chemotherapy, or immunotherapy for the current malignancy.
- Provision of written informed consent to participate in the study.
Who cannot join
- Presence of other concurrent systemic malignant tumors.
- Emergency surgery.
- Hospital stay less than 48 hours post-surgery.
- Incomplete critical clinical or nutritional data.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300170
About this study
Official title: Value Analysis of Preoperative Nutritional Risk Screening 2002 (NRS2002) and Global Leadership Initiative on Malnutrition (GLIM) Screening in Predicting Postoperative Complications in Patients With Gastrointestinal Malignancies
This prospective cohort study investigates and compares the predictive power of two nutritional assessment tools, the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study aims to determine how well these tools can predict postoperative complications in patients with gastrointestinal malignancies who are undergoing surgical resection.
Read the detailed description
Malnutrition is a common and severe problem in patients with gastrointestinal (GI) malignancies, adversely affecting surgical outcomes. This prospective cohort study was designed to evaluate and compare the predictive utility of two key nutritional assessment tools. Patients scheduled for elective curative-intent surgery for GI malignancies were enrolled. Within 24 hours of admission, each patient's nutritional status was assessed using both the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study followed these patients through their hospital stay and post-discharge to collect data on the primary outcome of postoperative complications, as well as secondary outcomes including length of hospital stay, hospitalization costs, and unplanned 30-day and 60-day readmissions. The objective is to provide evidence to guide clinicians in using NRS2002 and GLIM for preoperative risk stratification and to identify patients who may benefit from nutritional interventions to improve surgical outcomes.
- Conditions
- Gastrointestinal Malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Risk Group (NRS2002 ≥ 3) | Patients identified as being at nutritional risk based on the Nutritional Risk Screening 2002 (NRS2002) score (total score ≥ 3), assessed preoperatively within 24 hours of admission. These patients were followed to assess for postoperative outcomes. | |
| No Nutritional Risk Group (NRS2002 < 3) | Patients identified as not being at significant nutritional risk based on the NRS2002 score (total score < 3), assessed preoperatively within 24 hours of admission. These patients served as the control group for the NRS2002 exposure and were followed to assess for postoperative outcomes. | |
| Malnutrition Group (GLIM Criteria) | Patients diagnosed with malnutrition based on the Global Leadership Initiative on Malnutrition (GLIM) criteria, requiring at least one phenotypic and one etiologic criterion. Assessment was performed preoperatively within 24 hours of admission. Patients were followed to assess for postoperative outcomes. This group was also sub-categorized into moderate and severe malnutrition. | |
| No Malnutrition Group (GLIM Criteria) | Patients who did not meet the GLIM criteria for malnutrition. Assessment was performed preoperatively within 24 hours of admission. These patients served as the control group for the GLIM exposure and were followed to assess for postoperative outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Complications
Measured as the number of patients experiencing one or more postoperative complications. Complications were defined and graded according to the Clavien-Dindo classification system and the "Expert Consensus on Postoperative Complications Registration for Gastrointestinal Tumor Surgery (2018 Edition)". Major complications were defined as Clavien-Dindo grade III or higher.
Measured: Up to 30 days post-surgery
Secondary outcomes (4)
Length of Hospital Stay
The total duration of the index hospitalization, measured from the date of admission to the date of discharge.
Measured: Up to 60 days post-surgery (data collected at discharge)
Intensive Care Unit (ICU) Admission Rate
The percentage of patients admitted to the ICU at any point during their postoperative hospital stay.
Measured: Up to 30 days post-surgery
Unplanned 30-Day Readmission Rate
The percentage of patients who had an unplanned hospital readmission for any reason.
Measured: Within 30 days of discharge
Unplanned 60-Day Readmission Rate
The percentage of patients who had an unplanned hospital readmission for any reason.
Measured: Within 60 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Dec 2019
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MalignanciesStudies 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
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third central hospital of Tianjin affiliated Nankai university
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dongping Xu, Third central hospital of Tianjin affiliated Nankai university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104175
- Sponsor's protocol ID
- SZX-IRB-SOP-016(F)-002-01
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value Analysis of Preoperative Nutritional Risk Screening 2002 (NRS2002) and Global Leadership Initiative on Malnutrition (GLIM) Screening in Predicting Postoperative Complications in Patients With Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT07104175
- Acronym / sponsor ID
- SZX-IRB-SOP-016(F)-002-01
- Conditions
- Gastrointestinal Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Third central hospital of Tianjin affiliated Nankai universityResearch network
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 5 Aug 2025 (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.
This prospective cohort study investigates and compares the predictive power of two nutritional assessment tools, the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study aims to determine how well these tools can predict postoperative complications in patients with gastrointestinal malignancies who are undergoing surgical resection.
Detailed description
Malnutrition is a common and severe problem in patients with gastrointestinal (GI) malignancies, adversely affecting surgical outcomes. This prospective cohort study was designed to evaluate and compare the predictive utility of two key nutritional assessment tools. Patients scheduled for elective curative-intent surgery for GI malignancies were enrolled. Within 24 hours of admission, each patient's nutritional status was assessed using both the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study followed these patients through their hospital stay and post-discharge to collect data on the primary outcome of postoperative complications, as well as secondary outcomes including length of hospital stay, hospitalization costs, and unplanned 30-day and 60-day readmissions. The objective is to provide evidence to guide clinicians in using NRS2002 and GLIM for preoperative risk stratification and to identify patients who may benefit from nutritional interventions to improve surgical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nutritional Risk Group (NRS2002 ≥ 3) | – | –Patients identified as being at nutritional risk based on the Nutritional Risk Screening 2002 (NRS2002) score (total score ≥ 3), assessed preoperatively within 24 hours of admission. These patients were followed to assess for postoperative outcomes. |
| No Nutritional Risk Group (NRS2002 < 3) | – | –Patients identified as not being at significant nutritional risk based on the NRS2002 score (total score < 3), assessed preoperatively within 24 hours of admission. These patients served as the control group for the NRS2002 exposure and were followed to assess for postoperative outcomes. |
| Malnutrition Group (GLIM Criteria) | – | –Patients diagnosed with malnutrition based on the Global Leadership Initiative on Malnutrition (GLIM) criteria, requiring at least one phenotypic and one etiologic criterion. Assessment was performed preoperatively within 24 hours of admission. Patients were followed to assess for postoperative outcomes. This group was also sub-categorized into moderate and severe malnutrition. |
| No Malnutrition Group (GLIM Criteria) | – | –Patients who did not meet the GLIM criteria for malnutrition. Assessment was performed preoperatively within 24 hours of admission. These patients served as the control group for the GLIM exposure and were followed to assess for postoperative outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) with a new, histopathologically confirmed diagnosis of a primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer). These patients were admitted to a single tertiary care center for elective, curative-intent surgical resection between December 2019 and December 2024. The population represents individuals who had not received prior anti-tumor treatments for their current malignancy.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Histopathologically confirmed primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer).
- Planned curative-intent surgical resection.
- No prior anti-tumor treatments such as surgery, radiotherapy, chemotherapy, or immunotherapy for the current malignancy.
- Provision of written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Presence of other concurrent systemic malignant tumors.
- Emergency surgery.
- Hospital stay less than 48 hours post-surgery.
- Incomplete critical clinical or nutritional data.
- Refusal to participate.
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
Incidence of Postoperative Complications
Time frame: Up to 30 days post-surgery
Measured as the number of patients experiencing one or more postoperative complications. Complications were defined and graded according to the Clavien-Dindo classification system and the "Expert Consensus on Postoperative Complications Registration for Gastrointestinal Tumor Surgery (2018 Edition)". Major complications were defined as Clavien-Dindo grade III or higher.
4 secondary outcomes
Length of Hospital Stay
Time frame: Up to 60 days post-surgery (data collected at discharge)
Intensive Care Unit (ICU) Admission Rate
Time frame: Up to 30 days post-surgery
Unplanned 30-Day Readmission Rate
Time frame: Within 30 days of discharge
Unplanned 60-Day Readmission Rate
Time frame: Within 60 days of discharge
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 5 Aug 2025.
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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.
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 Gastrointestinal Malignancies, run by Third central hospital of Tianjin affiliated Nankai university at 1 site in 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 5 inclusion and 5 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 5 Aug 2025. 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 China. 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?
Incidence of Postoperative Complications (time frame: Up to 30 days post-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 5 Aug 2025.