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.
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.
José A. González González, MD contact
Mexico1 site, 1 recruiting
- 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
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.
- Conditions
- Common Bile Duct Calculi
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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.
- First posted1 Jun 2020
- Study start7 Jun 2019
- Primary completion30 May 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- José A. González González, MD, Study director, José Eleuterio González University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symbolic Regression Model To Predict Choledocholithiasis: Prospective Validation
- ClinicalTrials.gov ID
- NCT04410848
- Acronym / sponsor ID
- (SymChole) / GA19-00003
- Conditions
- Common Bile Duct Calculi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patient with suspicion of choledocholithiasis | – | Other: To determine the diagnostic of Choledocholithiasis with symbolic regression modelPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical suspicion of choledocholithiasis.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To determine the diagnostic of Choledocholithiasis with symbolic regression modelTo determine the diagnostic of Choledocholithiasis with symbolic regression model | Other | All patient with suspicion of choledocholithiasis |
Primary outcome
To validate prospectively a symbolic regression model to predict choledocholithiasis
Time frame: 72 horas
To validate a model to predict choledocholithiasis compared clinical predictors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José A. González González, MD contact
José A. González González, MD study director
José Eleuterio González University Hospital
1 site in 1 country: see every site and its status.
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.