Differentiation Benign and Malignant Pancreatic Lesions

NCT06641947 | Completed

• 1 other identifier: observational
• Study Type: observational
• Target: 864
• Locations: 1 country
• Sites: 1

Brief Summary

The MVIT-MLKA model, with its complex architecture combining CNNs and Transformers, excels in image feature extraction and capturing long-range dependencies. This gives it strong adaptability and robustness in lesion detection and classification tasks. Compared to traditional machine learning methods and other deep learning models, MVIT-MLKA not only performs better in terms of accuracy, sensitivity, and specificity but also helps reduce inter-observer variability, enhancing diagnostic consistency among physicians. Although the model showed slight fluctuations in performance on external datasets, it still outperforms other models overall and holds significant potential for clinical applications. With further optimization to improve its generalization capabilities, MVIT-MLKA could become a powerful tool for diagnosing benign and malignant lesions, providing more consistent and accurate support in clinical practice.

Conditions

Pancreatic Tumor

Outcome Measures

Primary Outcomes (1)

• overall survival time

  The main outcome measure in this study was overall survival (OS), calculated from the date of the initial surgery to the date of death from any cause or the last follow-up.

  1 year

Study Arms (1)

benign and malignant

Benign Lesion Group: This cohort includes patients diagnosed with benign pancreatic lesions, such as pancreatic cysts or neuroendocrine tumors. These patients typically do not require aggressive treatments like surgery or chemotherapy and are managed with regular monitoring and non-invasive interventions. Histopathological confirmation or stability over a minimum of one year of follow-up without progression is used to classify lesions as benign. Malignant Lesion Group: This cohort comprises patients diagnosed with malignant pancreatic lesions, such as pancreatic ductal adenocarcinoma (PDAC). These patients often require more aggressive treatment options, including surgery, chemotherapy, and radiotherapy. The malignancy of the lesions is confirmed through histopathological analysis, and the cohort focuses on cases with clear evidence of tumor growth and progression.

Procedure: Whipple procedure

Interventions

Whipple procedure PROCEDURE

Typically used for treating pancreatic cancer, particularly tumors located in the head of the pancreas.

benign and malignant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all people were selected from three medical centers in chongqing province

You may qualify if:

• All patients with malignant pancreatic lesions had confirmed histopathology according to the 8th edition of the American Joint Committee on Cancer TNM staging system \[25\]; Lesions were classified as benign if they had either histopathologic confirmation or demonstrated benign characteristics with stability over at least one year of follow-up on CT or MRI imaging; (2) Patients underwent preoperative abdominal contrast-enhanced CT scans; (3) No anti-tumor treatment was conducted before the CT scan

You may not qualify if:

• (1) Patients with significant motion artifacts or other imaging issues; (2) A time gap of one month or more between the CT scan and subsequent surgery; (3) Tumors less than 10 mm in maximum diameter.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: January 11, 2022
• Primary Completion: March 5, 2024
• Study Completion: September 20, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)