Radiomic fEatures of Pancreas From Contrast Enhanced CT Image Predict One-Year RecUrrence Risk of Acute PancReatitis

NCT05778929 | Unknown

• 1 other identifier: 2022PHB174-001
• Study Type: observational
• Target: 694
• Locations: 0 countries
• Sites: N/A

Brief Summary

One-year recurrence rate of acute pancreatitis at about 20%. 36% of the patients with recurrent acute pancreatitis will develop into chronic pancreatitis. In addition to negative impact on patient's quality of life, chronic pancreatitis is also associated with the occurrence of pancreatic cancer. The etiology of recurrent acute pancreatitis (RAP) can be divided into mechanical obstructive factors (e.g. cholelithiasis, cholestasis), metabolic abnormality and toxic substance factors (e.g. hyperlipidemia and alcoholism), and other or idiopathic factors. At present, the diagnosis and treatment of RAP remains highly challenging. Early identification and intervention on risk factors of recurrence will be effective in reducing incidence and improving prognosis. Contrast-enhanced Computed Tomography (CT) can not only provide more imaging information and further assess the severity of acute pancreatitis, but also aid in the differentiation of other diseases associated with acute abdominal pain. In addition, radiomics based on raw radiographic data has become a research hotspot in recent years. The purpose of this study is to establish and validate a deep learning model based on high concentration iopromide-enhanced abdominal CT images which is designed to predict the recurrence of pancreatitis in patients with first episode of pancreatitis within the 1-year follow-up period.

Conditions

Pancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of the model established with relevant clinical factors and radiomic features

  Image acquisition at each site is performed by an independent radiologist with ≥ 5 years of work experience. Radiomics features will be extracted from 370 mgI/ml Iopromide-enhanced pancreatic CT obtained within 14 days after the first onset of symptoms to quantitative predict the first recurrence of acute pancreatitis in 12 months follow-up period.Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive TP+FN+TN+FP=Total number of patients.

  12 months

Secondary Outcomes (5)

• The total number of subjects who developed the first recurrence of acute pancreatitis (subjects with multiple recurrences, calculated and analyzed according to the time of the earliest recurrence) within 3, 6 and 12 months

  in 12 months follow up period

• The sensitivity and specificity of the deep-learning integrated model established with relevant clinical factors and radiomic features to quantitative predict overall recurrence of acute pancreatitis in 3 and 6 months follow-up period;

  3 months, 6 months

• The image quality of Iopromide-enhanced pancreatic CT images obtained within 14 days after onset of symptoms

  14 days

• The sensitivity and specificity of the model determined by radiomics features extracted from images with high quality scores (2-3 points)

  3 months, 6 months and 12 months

• The sensitivity and specificity of the radiomics features in predicting (the first) recurrence of different types and severities of acute pancreatitis at 3, 6 and 12 months

  3 months, 6 months and 12 months

Study Arms (2)

patients diagnosed as recurrent acute pancreatitis in 12 month

Recurrent acute pancreatitis: relapse occurs more than three months after the previous episode ended, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis.

Diagnostic Test: Radiomics Model

patients not diagnosed as recurrent acute pancreatitis in 12 months

No relapse occurs more than three months after the previous episode ended, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis.

Diagnostic Test: Radiomics Model

Interventions

Radiomics Model DIAGNOSTIC_TEST

A total of 694 consecutive eligible patients with first episode of "acute pancreatitis" that recommended for iopromide 370 mgI/ml enhanced pancreatic CT scan within 14 days after onset of symptoms (the sample size ratio of training set: test set: validation set is 5:2:3) will be sequentially enrolled at 10 sites (This study is observational in nature. The routine enhanced pancreatic CT protocol at all selected sites is similar or equivalent to that used in the PI site in the study). Relevant clinical information of the enrolled subjects is collected. Radiomics features are extracted from the selected regions of interest on pancreatic CT images and classified. The subjects are followed up for 12 months and divided into recurrent group and non-recurrent group according to the first recurrence status.

patients diagnosed as recurrent acute pancreatitis in 12 month; patients not diagnosed as recurrent acute pancreatitis in 12 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects enrolled in this prospective study are adult patients diagnosed as the first onset of acute pancreatitis and recommended for enhanced pancreatic CT scan within 14 days after onset of symptoms and accepted follow-up via telephone or returning to the site at 1, 3, 6 and 12 months.

You may qualify if:

• years old
• The subject met the following three criteria and diagnosed with acute pancreatitis according to the Atlanta Classification of Acute Pancreatitis.
• Abdominal pain indicative of pancreatitis 2.2 Serum levels of amylase or lipase \>3 times the upper limit of normal 2.3 Characteristic findings from abdominal imaging (unenhanced CT\\MR\\ultrasonography)
• Referred for an enhanced CT examination with Iopromide 370 in 14 days after symptom onset by clinicians
• Sign the informed consent

You may not qualify if:

• Has history of allergy to iodinated contrast agent
• Confirmed or suspected hyperthyroidism or pheochromocytoma;
• Pregnant or lactating women
• Patients who are participating another clinical study
• Disturbance of consciousness
• Has a history of acute pancreatitis
• Has acute attack of chronic pancreatitis
• Has a history of pancreatic surgery
• Has co-morbidities such as cancer or other severe chronic wasting diseases
• Has a history of other surgeries or surgical implants that affects imaging and quality of pancreatic imaging
• Typical indications for pancreatic surgery, gallbladder surgery or endoscopic retrograde cholangiopancreatography as judged by the clinician
• Any patient who is considered unsuitable for iodinated contrast agent-enhanced pancreatic CT scan at the discretion of the investigator

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 22, 2023

Record last verified: 2023-03