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NCT Number: NCT05961826

COLPAC (RaDiCo Cohort) (RaDiCo-COLPAC)

The goal of this observational study is to describe the various clinical, biological and radiological manifestations of LPAC syndrome, defined according to standard diagnostic criteria, or according to criteria extended to all symptomatic recurrent biliary lithiasis, and delineate the various possible evolutions.

Participants will be followed for 5 years and the inclusion sites will collect the necessary data at least once a year as part of routine patient care. A quality of life self-questionnaire will be completed by participants during these visits.

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Key information

Conditions

Low Phospholipid Associated Cholelithiasis

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal Aix-Pertuis, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children or adults meeting the standard* or extended** diagnostic criteria for LPAC syndrome:
  • First symptoms before the age of 40 years
  • Radiological images compatible with the existence of intrahepatic lithiasis
  • Recurrence of symptoms after cholecystectomy

(*) standard criteria: symptomatic biliary lithiasis with at least 2 out of 3 criteria

(**) extended criteria: symptomatic biliary lithiasis with 1 out of 3 criteria

Exclusion criteria

  • Patients who have undergone liver transplantation

Treatment and study plan

Primary outcomes

  1. Descriptive analysis of the clinical manifestations of LPAC syndrome like personal and family medical history of the disease, clinical features, medical complications, co-morbidities, death (age of onset and cause).

    Time frame: Through study completion, an average of 5 years

  2. Descriptive analysis of the biological manifestations of LPAC syndrome like hepatic biochemical tests and glucido-lipid tests

    Time frame: Through study completion, an average of 5 years

  3. Descriptive analysis of the radiological manifestations of LPAC syndrome like presence of stones or signs of intrahepatic, vesicular or main bile duct micro-lithiasis

    Time frame: Through study completion, an average of 5 years

Secondary outcomes

  1. Description of diagnostic practices by a descriptive analysis of sequences of medical procedures used to diagnose LPAC syndrome.

    Time frame: Through study completion, an average of 5 years

  2. Description of therapeutic practices by a descriptive analysis of the different curative and symptomatic treatments offered depending on the stage of the disease and the type of extra-hepatic complications.

    Time frame: Through study completion, an average of 5 years

  3. Description of patient management practices.

    Time frame: Through study completion, an average of 5 years

  4. Identification of new diagnostics by refining the collection of semiological fields of 1st degree relatives and including patients with recurrent symptomatic biliary lithiasis who do not fully meet the current diagnostic criteria for LPAC syndrome

    Time frame: Through study completion, an average of 5 years

    The extension of the criteria will be proposed on the basis of the collection of all the semiological fields of patients diagnosed with an LPAC syndrome defined according to the usual or extended criteria and their 1st degree relatives.

    The extended diagnostic criteria are :

    • Age of onset of the disease over 40 years of age
    • The presence of recurrent biliary lithiasis without radiological signs characteristic of LPAC syndrome (comet tails or intrahepatic lithiasis).

    Patients with symptomatic gallstones who have only one of the 3 criteria for LPAC syndrome (onset before the age of 40, intrahepatic microlithiasis, recurrence after cholecystectomy).

  5. Evaluation of response to medical and interventional treatments.

    Time frame: Through study completion, an average of 5 years

    This evaluation criterion will be the search for correlation between response or non-response to medical and interventional treatments. This will be analysed by looking at the presence or absence of certain clinical, biochemical, molecular and radiological features of the disease such as :

    • No reduction in the frequency or intensity of painful attacks.
    • No reduction in the number of complications.
    • No improvement or normalisation of liver tests.
    • No regression or disappearance of radiological signs of intrahepatic lithiasis
    • No improvement in the criteria for assessing quality of life and impact on social life

  6. Identification of prognostic factors (clinical, biochemical, radiological) associated with a poor therapeutic response by assessing the occurrence of events such as : - Fatal or non-fatal complications - Death due to hepatic or other causes

    Time frame: Through study completion, an average of 5 years

  7. Assessing the impact of LPAC syndrome on quality of life.

    Time frame: Through study completion, an average of 5 years

    Impact of disease on quality of life will be evaluated through scores of quality of life questionnaires (SF-36)

  8. Evaluation of the proportion of patients referred to LPAC within the population referred to the hepatology and/or digestive surgery departments for biliary lithiasis during the same study period

    Time frame: Through study completion, an average of 5 years

    The relative prevalence of LPAC syndrome (number of cases of LPAC syndrome compared with the number of cases of gallbladder disease) will be measured from 1 March 2016 to 28 February 2017, based on cases recorded in the centres participating in the study.

    The relative incidence (number of new cases of LPAC syndrome compared with the number of new cases of gallstones) will be measured over the same period, in the same centres.

    The total number of patients seen in hospital or in consultation during the same period for gallstones will be collected in each participating hospital using the pmsi code.

Other outcomes

  1. Deepening the study of the genotype/phenotype correlations of the ABCB4 gene with assessment of the number of painful attacks and complications, presence of radiological signs, measurement of biological assays, good or poor response to treatment

    Time frame: Through study completion, an average of 5 years

  2. Documenting the genetic transmission profile and heritability (penetrance) of the LPAC syndrome by analysing the phenotypes and genotypes of patients and their 1st degree relatives (whether or not they have declared illness).

    Time frame: Through study completion, an average of 5 years

    The evaluation criteria will be :

    • the collection of common genetic mutations in the patient and 1st degree relatives (carried out as part of the diagnostic study of the index case)
    • the search for common phenotypes in the patient and 1st degree relatives (carried out as part of the diagnostic study of the index case)

  3. Search for new susceptibility genes in patients without gene alterations of ABCB4

    Time frame: Through study completion, an average of 5 years

  4. Search for modulating genes in mutated and non-mutated ABCB4 patients.

    Time frame: Through study completion, an average of 5 years

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

National Cohort About Epidemiology, Clinical and Genetic Heterogeneity of the "Low-Phospholipid-Associated Cholelithiasis" (LPAC) Syndrome

Acronym: COLPAC

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.