Low Phospholipid Associated CholelithiasisCOLPACNCT05961826
COLPAC (RaDiCo Cohort) (RaDiCo-COLPAC)
An observational study of Low Phospholipid Associated Cholelithiasis, run by Institut National de la Santé Et de la Recherche Médicale, France at 21 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Low Phospholipid Associated Cholelithiasis
- How many people
- 650 participants
- Where
- 21 sitesFrance
- Study dates
- 6 Nov 2017to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study concerns all prevalent and incident patients who meet the standard or extended diagnostic criteria for LPAC syndrome, whatever the existing genetic data concerning ABCB4, or who have been referred as having a mutation in the ABCB4 gene in a clinical context of biliary lithiasis.
Who may be able to join
- 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
Who cannot join
- Patients who have undergone liver transplantation
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence
Centre Hospitalier Annecy Genevois
Annecy
Hôpital Avicenne
Bobigny
Hôpital Haut-Lévêque
Bordeaux
Hôpital Saint Camille
Bry-sur-Marne
Hôpital Côte de Nacre
Caen
Hôpital Beaujon
Clichy
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Centre Hospitalier Intercommunal de Créteil
Créteil
Hôpital François Mitterrand
Dijon
Hôpital Michallon
Grenoble
Hôpital Claude Huriez
Lille
Hôpital de la Croix-Rousse
Lyon
Centre hospitalier régional d'Orléans
Orléans
Hôpital Saint-Antoine
Paris
Hôpital Jean Bernard
Poitiers
Hôpital Robert Debré
Reims
Hôpital Charles Nicolle
Rouen
Hôpital Civil
Strasbourg
Hôpital Rangueil
Toulouse
Hôpital Paul Brousse
Villejuif
About this study
Official title: National Cohort About Epidemiology, Clinical and Genetic Heterogeneity of the "Low-Phospholipid-Associated Cholelithiasis" (LPAC) Syndrome
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 5 years
Descriptive analysis of the biological manifestations of LPAC syndrome like hepatic biochemical tests and glucido-lipid tests
Measured: Through study completion, an average of 5 years
Descriptive analysis of the radiological manifestations of LPAC syndrome like presence of stones or signs of intrahepatic, vesicular or main bile duct micro-lithiasis
Measured: Through study completion, an average of 5 years
Secondary outcomes (8)
Description of diagnostic practices by a descriptive analysis of sequences of medical procedures used to diagnose LPAC syndrome.
Measured: Through study completion, an average of 5 years
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.
Measured: Through study completion, an average of 5 years
Description of patient management practices.
Measured: Through study completion, an average of 5 years
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
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).
Measured: Through study completion, an average of 5 years
Evaluation of response to medical and interventional treatments.
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
Measured: Through study completion, an average of 5 years
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
Measured: Through study completion, an average of 5 years
Assessing the impact of LPAC syndrome on quality of life.
Impact of disease on quality of life will be evaluated through scores of quality of life questionnaires (SF-36)
Measured: Through study completion, an average of 5 years
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
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.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Nov 2017
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Phospholipid Associated CholelithiasisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christophe CORPECHOT, Principal investigator, INSERM UMR_S938
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961826
- Sponsor's protocol ID
- C16-14
- Acronym
- COLPAC
- Status last verified
- Feb 2026
- First submitted
- 6 Jul 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cohort About Epidemiology, Clinical and Genetic Heterogeneity of the "Low-Phospholipid-Associated Cholelithiasis" (LPAC) Syndrome
- ClinicalTrials.gov ID
- NCT05961826
- Acronym / sponsor ID
- COLPAC / C16-14
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Jul 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study concerns all prevalent and incident patients who meet the standard or extended diagnostic criteria for LPAC syndrome, whatever the existing genetic data concerning ABCB4, or who have been referred as having a mutation in the ABCB4 gene in a clinical context of biliary lithiasis.
Key inclusion criteria (6 listed)
- Children or adults meeting the standard* or extended** diagnostic criteria for LPAC syndrome:
- () standard criteria: symptomatic biliary lithiasis with at least 2 out of 3 criteria
- () extended criteria: symptomatic biliary lithiasis with 1 out of 3 criteria
Key exclusion criteria (1 listed)
- Patients who have undergone liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
8 secondary outcomes
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
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
Description of patient management practices.
Time frame: Through study completion, an average of 5 years
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
Evaluation of response to medical and interventional treatments.
Time frame: Through study completion, an average of 5 years
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
Assessing the impact of LPAC syndrome on quality of life.
Time frame: Through study completion, an average of 5 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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.
Christophe CORPECHOT principal investigator
INSERM UMR_S938
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Phospholipid Associated Cholelithiasis, run by Institut National de la Santé Et de la Recherche Médicale, France at 21 sites in France.
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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 12 Feb 2026.