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Common Bile Duct Calculi(SymChole)NCT04410848

Symbolic Regression Model To Predict Choledocholithiasis

An observational study of Common Bile Duct Calculi, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Common Bile Duct Calculi
What is being tested?
To determine the diagnostic of Choledocholithiasis with symbolic regression model
How many people
200 participants
Where
1 siteMexico
Study dates
7 Jun 2019to 31 Jul 2020
How long will I take part?
1 Year
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: Patients with clinical suspicion of choledocholithiasis.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Carlos A. Herrera Figueroa, M.D contact

+52 8127319026

carale30@hotmail.com

José A. González González, MD contact

jalbertogastro@gmail.com

Mexico1 site, 1 recruiting
  • Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León, 64460

    Carlos A. Herrera Figueroa, M.D, +51 8127319026, carale30@hotmail.com

    José A. González Gonzáles, MD, jalbertogastro@gmail.com

    Recruiting

Other trials in Mexico

About this study

Official title: Symbolic Regression Model To Predict Choledocholithiasis: Prospective Validation

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.

Read the detailed description

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 to perform endoscopic retrograde cholangiopancreatography (ERCP) is a very important aspect, due to the economic aspects and possible complications. By making a proper patient selection for additional studies or procedure, then the costs, complications and days of stay would be reduced. Avoiding the unnecessary use of ERCP would avoid its 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.

Having the historical database of the University Hospital (HU), regarding clinical, laboratory and image variables of patients with suspected choledocholithiasis, using a symbolic regression method, several randomly formed equations are generated. Each equation deducts its coefficient of linear correlation (Pearson's correlation).

For the following study we admitted to the emergency department of adults at the University Hospital all patients with clinical suspicion of choledocholithiasis, who meet the inclusion criterion. The study which is realized is a normal one based on the method of clinical predictors, obtaining laboratory studies, image studies, and patient management will be carried out based on the method of clinical predictors. The calculation is made with the equation obtained, and the patient is monitored until discharge. The calculation obtained from the equation will not be taken into account for the decisions in the management of the patient. The variables studied as white blood cells, total bilirubin values, direct bilirubin, indirect bilirubin, Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), alkaline phosphatase (AP), gamma-glutamyl transpeptidase (GGT) at admission will be taken from the clinical record. Transabdominal ultrasonography will be performed upon admission by the diagnostic radiology department of the HU and the size of the bile duct in mm, presence of gallbladder gallstones and bile duct stones will be taken from the report. ERCP, magnetic resonance cholangiopancreatography (MRCP) or intraoperative cholangiography will be performed and one will be taken as a confirmation of choledocolithiasis, and its absence would rule it out.

Being tested
To determine the diagnostic of Choledocholithiasis with symbolic regression model
Medical subject headings
Gallstones

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To determine the diagnostic of Choledocholithiasis with symbolic regression modelOther

    To determine the diagnostic of Choledocholithiasis with symbolic regression model

Study groups in NCT04410848
Study groupRoleWhat they receive
All patient with suspicion of choledocholithiasisPatient 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.
Receives: Other: To determine the diagnostic of Choledocholithiasis with symbolic regression model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To validate prospectively a symbolic regression model to predict choledocholithiasis

    To validate a model to predict choledocholithiasis compared clinical predictors.

    Measured: 72 horas

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start7 Jun 2019
  3. Primary completion30 May 2020 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410848
Sponsor's protocol ID
GA19-00003
Acronym
(SymChole)
Status last verified
May 2020
First submitted
20 Jan 2020
Last updated
1 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Common Bile Duct Calculi, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jun 2020. 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 Mexico. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carlos A. Herrera Figueroa, M.D (+52 8127319026, carale30@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To validate prospectively a symbolic regression model to predict choledocholithiasis (time frame: 72 horas). 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 1 Jun 2020.

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