Symbolic Regression Model To Predict Choledocholithiasis

NCT04410848 | Unknown

• 1 other identifier: GA19-00003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Choledocholithiasis refers to the presence of gallstones within the common bile duct. It is proposed to look for markers that help in the diagnosis and in differentiating between retained and migrated gallstones. The selection of patients is a very important aspect, due to the economic aspects and possible complications. Taking advantage of the development of technology, the improvement in computer systems, the use of artificial intelligence and a symbolic regression model that works to predict the presence of choledocholithiasis and provide evidence that clarifies the treatment of patients with this pathology, especially in this group where there is a bigger controversy.

Conditions

Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (1)

• To validate prospectively a symbolic regression model to predict choledocholithiasis

  To validate a model to predict choledocholithiasis compared clinical predictors.

  72 horas

Study Arms (1)

All patient with suspicion of choledocholithiasis

Patient with the suspect of common biliary duct stone for pain type colic in the right upper quadrant abdomen, the elevation of bilirubin, alkaline phosphatase, pancreatitis, dilated common bile duct and cholangitis. According to the criteria to assign the risk of choledocholithiasis. We are going to validate a scale based on intelligence artificial compared to the clinical predictor.

Other: To determine the diagnostic of Choledocholithiasis with symbolic regression model

Interventions

To determine the diagnostic of Choledocholithiasis with symbolic regression model OTHER

To determine the diagnostic of Choledocholithiasis with symbolic regression model

All patient with suspicion of choledocholithiasis

Eligibility Criteria

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

Study Population

Patients with clinical suspicion of choledocholithiasis.

You may qualify if:

• Patients above 18 with clinical suspicion of choledocholithiasis by biliary-type pain, laboratory testing that reveals a cholestatic pattern of liver test abnormalities, biliary pancreatitis or dilated common bile duct

You may not qualify if:

• Patient with a history of cholecystectomy
• History of previous ERCP or surgery involving bile duct
• Patient who could not be followed
• Patient with other pathology that causes alteration of liver function test.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• José A. González González, MD

  José Eleuterio González University Hospital

  STUDY DIRECTOR

Central Study Contacts

Carlos A. Herrera Figueroa, M.D

CONTACT

+52 8127319026; carale30@hotmail.com

José A. González González, MD

CONTACT

jalbertogastro@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: June 1, 2020
• Study Start: June 7, 2019
• Primary Completion: May 30, 2020
• Study Completion: July 31, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)