Predictive Effect of Abdominal Fat and Muscle Area Calculated Based on Abdominal CT on Gastric Cancer Patients

Predictive Effect of Abdominal Fat and Muscle Area Calculated Based on Abdominal CT on Short- and Long-term Outcomes in Patients with Gastric Cancer

This study aims to create a clinical prediction model. Abdominal fat and muscle area also play an important role in the prediction of surgical outcomes in colorectal cancer. Studies have shown that excess visceral fat and low skeletal muscle mass (sarcopenia) are associated with poorer postoperative outcomes, including a higher risk of postoperative complications and lower survival. Preoperative imaging techniques such as CT, MRI and ultrasound that provide accurate measurements to assess abdominal fat and muscle area can help surgeons develop individualized surgical and rehabilitation plans, improve surgical success, reduce complications and improve long-term patient prognosis. In this study, the investigators expected to construct a prediction model of abdominal fat and muscle area on the short- and long-term outcomes of gastric and colorectal cancer patients by calculating the abdominal fat and muscle area in different levels of abdominal CT images, in order to further adjust and guide the treatment plan.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Sarcopenia; Gastric Cancers; Obesity and Overweight
• Intervention / Treatment: Other: Skeletal muscle, subcutaneous fat and visceral fat area

Detailed Description

This is a retrospective observational study, which is expected to include patients diagnosed with gastric cancer and undergoing radical gastric cancer surgery in the Department of Gastrointestinal Surgery of the First Affiliated Hospital of Chongqing Medical University, the Department of Gastrointestinal Surgery of the Second Affiliated Hospital of Chongqing Medical University, the Department of Gastrointestinal Surgery of the Affiliated Yongchuan Hospital of Chongqing Medical University, and the Department of Gastrointestinal Surgery of the Qijiang People's Hospital, and to discuss the predictive effects of abdominal fat and muscle area on the short-term and long-term outcomes of gastric cancer patients after surgery.

1. Case collection Patients diagnosed with gastric cancer and undergoing radical gastric cancer surgery were screened according to the inclusion criteria. All patients had signed informed consent.

Inclusion criteria:

1. Diagnosed with gastric cancer by pathology or cytology;
2. Age >18 years;
3. Not having received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
4. Patients with postoperative pathological stages other than stage IV, or without metastases in liver, lung or other distant organs confirmed by CT, MRI or B-ultrasound imaging and without surgical treatment;
5. Pre-operative CT examination data were kept in our hospital.

2. Data collection Collect patients' preoperative baseline information such as gender, age, body mass index (BMI), complications, tumor stage, etc. Collect patients' preoperative CT scans (make sure to include images from lumbar 1 to lumbar 5). Collect patients' surgical conditions such as operation time and intraoperative bleeding. Collect patients' postoperative complications during hospitalization; 3. Prognostic follow-up Closely follow up the death or cancer recurrence of patients after surgery. 4. Outcome indicators

1. Primary outcome indicators: overall survival (OS), disease-free survival (DFS), postoperative complications.
2. Secondary outcome indicators: postoperative recovery time, hospitalization time, postoperative weight change.

5. Image processing 3D Slicer was used to outline the range of subcutaneous fat, visceral fat, and muscle at the level of waist 1 to waist 5 on enhanced CT (5.0mm) images. Export the segmentation result as gpj.format, and select the Area Reading Calculator to calculate the area of fat and muscle at each level. Calculate fat area and muscle area at each level, calculate overall abdominal fat area and muscle area, and use the ratio of fat area to muscle area (e.g., visceral fat/skeletal muscle) as a predictor to generate the desired quantitative analyses.

6. Statistical Analysis

1. Basic characteristics and imaging indices were described as mean and standard deviation or median and standard deviation.
2. Univariate analysis including Kaplan-Meier survival analysis and Log-rank test were used to evaluate the effects of fat and muscle area on postoperative survival and complications.
3. Multivariate analysis including Cox regression models or Logistic regression models were used to evaluate the independent predictive role of abdominal fat and muscle area on surgical outcomes, controlling for potential confounders (e.g., age, gender, BMI, tumor stage, etc.).

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 400016
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 402160
      • The Affiliated Yongchuan Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients diagnosed with gastric and colorectal cancer and undergoing radical surgery for gastric and colorectal cancer at the study centre.

Description

Inclusion Criteria:

1. Diagnosis of gastric cancer or colorectal cancer confirmed by pathology or cytology;
2. aged >18 years;
3. not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
4. post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.
5. patients who have pre-operative CT examination data kept in our hospital.

Exclusion Criteria:

1. Poor quality of preoperative CT images;
2. refusal to participate in this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.	From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative complications	Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.	From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Collaborators: The Second Affiliated Hospital of Chongqing Medical University; The Affiliated Yongchuan Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• Han J, Liu X, Tang M, Yang F, Ding Z, Wu G. Abdominal fat and muscle distributions in different stages of colorectal cancer. BMC Cancer. 2023 Mar 28;23(1):279. doi: 10.1186/s12885-023-10736-2.
• Sun J, Lv H, Zhang M, Li M, Zhao L, Zeng N, Liu Y, Wei X, Chen Q, Ren P, Liu Y, Zhang P, Yang Z, Zhang Z, Wang Z. The Appropriateness Criteria of Abdominal Fat Measurement at the Level of the L1-L2 Intervertebral Disc in Patients With Obesity. Front Endocrinol (Lausanne). 2021 Dec 14;12:784056. doi: 10.3389/fendo.2021.784056. eCollection 2021.
• Koh H, Hayashi T, Sato KK, Harita N, Maeda I, Nishizawa Y, Endo G, Fujimoto WY, Boyko EJ, Hikita Y. Visceral adiposity, not abdominal subcutaneous fat area, is associated with high blood pressure in Japanese men: the Ohtori study. Hypertens Res. 2011 May;34(5):565-72. doi: 10.1038/hr.2010.271. Epub 2011 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: surgery; sarcopenia; gastrointestinal cancer; Visceral fat; Subcutaneous Fat
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Overnutrition; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Stomach Neoplasms; Overweight; Sarcopenia
• Other Study ID Numbers: ZZ2024-158-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No