Acute Biliary PancreatitisCAPABLESNCT05549349
ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis
An observational study of Acute Biliary Pancreatitis, run by Julia TRAVAGLI at 1 site in France.
Trial summary
The main objective of this work is to evaluate the recurrence of biliary episodes before cholecystectomy (hepatic colic, lithiasic migration, cholangitis, cholecystitis, pancreatitis, necrosis infections) in patients with acute biliary pancreatitis of any severity depending on the type of nutrition (oral, enteral or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Biliary Pancreatitis
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 10 Jul 2024
- How long will I take part?
- 6 Months
- 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: Recruitment of patients will be done in the gastroenterology departments of participating Hospitals. Information to patients will be provided by an investigator from the service. Participation in this study will be offered to all patients fulfilling the inclusion and non-inclusion criteria. A specific written information note as well as clear and honest oral information will be given to patients meeting the inclusion criteria, before collecting their non-objection. After collection of the patient's non-objection and allocation of a patient code, the investigator or his representative will complete an observation book (Case Report Form in English, CRF). This observation book will include clinical and paraclinical data from the patient's medical file.
Who may be able to join
- Adult over 18 years old
- Affiliated to a social security scheme.
- Patients with acute biliary pancreatitis
Who cannot join
- Patients with chronic pancreatitis
- Patients with a previous cholecystectomy
- Patients under guardianship, curatorship or legal protection
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this work is to evaluate the recurrence of biliary episodes before cholecystectomy (hepatic colic, lithiasic migration, cholangitis, cholecystitis, pancreatitis, necrosis infections) in patients with acute biliary pancreatitis of any severity depending on the type of nutrition (oral, enteral or parenteral).
Read the detailed description
Acute pancreatitis (AP) is one of the frequent causes of hospitalization in gastroenterology with an annual incidence of 13-45 cases per 100,000 patients. If we refer to the data in the white paper, hospitalizations for abdominal emergencies, such as PA, take place in at least 60% of cases in General Hospital Centers (CHG). Among these AP, approximately 40% of AP are secondary to a biliary lithiasis pathology. The main modalities of the initial management of AP have been the subject of several national and international recommendations and consensuses. Although it is well accepted that early refeeding during the first 48 hours reduces the appearance of a systemic inflammatory response syndrome (SIRS) or a collection infection, the feeding methods in the event of pancreatitis Acute biliary (ABP) during the acute phase using the oral route if it is tolerated or the enteral route by nasogastric tube before cholecystectomy remains debated.
Thus, in case of delayed cholecystectomy after AP, there is no consensus on the feeding methods after the acute phase (oral or enteral) until cholecystectomy nor on the benefit of a prophylactic endoscopic sphincterotomy in the absence of cholangitis.
- Conditions
- Acute Biliary Pancreatitis
- Being tested
- Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Gallbladder removal
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy during hospitalization | In this group, patients will have their cholecystectomy during the initial hospitalization. We will look at the mode of feeding between the biliary crisis and the cholecystectomy. Receives: Procedure: Cholecystectomy | |
| Delayed cholecystectomy | In this group, patients will have their cholecystectomy deferred from their initial hospitalization for various reasons. They will be seen again 3 months after leaving hospital. They will or will not have been cholecystectomized during this interval. Their mode of feeding as well as biliary events will be studied. Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
biliary events
Assess the recurrence of biliary events before cholecystectomy
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start10 Oct 2022
- Primary completion10 Oct 2022
- Study completion10 Jul 2024
Why it stopped: Studies are finshed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Biliary PancreatitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Julia TRAVAGLI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia TRAVAGLI, Poissy-Saint Germain Hospital
- Investigators
- Frederick MORRYOUSSEF, MD, Principal investigator, Poissy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549349
- Sponsor's protocol ID
- 2022-A00303-40
- Acronym
- CAPABLES
- Status last verified
- Mar 2025
- First submitted
- 19 Sep 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis
- ClinicalTrials.gov ID
- NCT05549349
- Acronym / sponsor ID
- CAPABLES / 2022-A00303-40
- Conditions
- Acute Biliary Pancreatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Studies are finshed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Julia TRAVAGLIUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 22 Sep 2022 (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 main objective of this work is to evaluate the recurrence of biliary episodes before cholecystectomy (hepatic colic, lithiasic migration, cholangitis, cholecystitis, pancreatitis, necrosis infections) in patients with acute biliary pancreatitis of any severity depending on the type of nutrition (oral, enteral or parenteral).
Detailed description
Acute pancreatitis (AP) is one of the frequent causes of hospitalization in gastroenterology with an annual incidence of 13-45 cases per 100,000 patients. If we refer to the data in the white paper, hospitalizations for abdominal emergencies, such as PA, take place in at least 60% of cases in General Hospital Centers (CHG). Among these AP, approximately 40% of AP are secondary to a biliary lithiasis pathology. The main modalities of the initial management of AP have been the subject of several national and international recommendations and consensuses. Although it is well accepted that early refeeding during the first 48 hours reduces the appearance of a systemic inflammatory response syndrome (SIRS) or a collection infection, the feeding methods in the event of pancreatitis Acute biliary (ABP) during the acute phase using the oral route if it is tolerated or the enteral route by nasogastric tube before cholecystectomy remains debated.
Thus, in case of delayed cholecystectomy after AP, there is no consensus on the feeding methods after the acute phase (oral or enteral) until cholecystectomy nor on the benefit of a prophylactic endoscopic sphincterotomy in the absence of cholangitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy during hospitalization | – | Procedure: CholecystectomyIn this group, patients will have their cholecystectomy during the initial hospitalization. We will look at the mode of feeding between the biliary crisis and the cholecystectomy. |
| Delayed cholecystectomy | – | Procedure: CholecystectomyIn this group, patients will have their cholecystectomy deferred from their initial hospitalization for various reasons. They will be seen again 3 months after leaving hospital. They will or will not have been cholecystectomized during this interval. Their mode of feeding as well as biliary events will be studied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of patients will be done in the gastroenterology departments of participating Hospitals. Information to patients will be provided by an investigator from the service. Participation in this study will be offered to all patients fulfilling the inclusion and non-inclusion criteria. A specific written information note as well as clear and honest oral information will be given to patients meeting the inclusion criteria, before collecting their non-objection. After collection of the patient's non-objection and allocation of a patient code, the investigator or his representative will complete an observation book (Case Report Form in English, CRF). This observation book will include clinical and paraclinical data from the patient's medical file.
Key inclusion criteria (3 listed)
- Adult over 18 years old
- Affiliated to a social security scheme.
- Patients with acute biliary pancreatitis
Key exclusion criteria (3 listed)
- Patients with chronic pancreatitis
- Patients with a previous cholecystectomy
- Patients under guardianship, curatorship or legal protection
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 |
|---|---|---|
| CholecystectomyGallbladder removal | Procedure or surgery | Cholecystectomy during hospitalization, Delayed cholecystectomy |
Primary outcome
biliary events
Time frame: 3 month
Assess the recurrence of biliary events before cholecystectomy
Results and safety
The study was stopped early (reason given: Studies are finshed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Influence of Gut Microbiome in Gallstone Disease
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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.
Frederick MORRYOUSSEF, MD principal investigator
Poissy
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 Acute Biliary Pancreatitis, run by Julia TRAVAGLI at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Mar 2025. 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 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?
The study was stopped early (reason given: Studies are finshed). Results are not available in the source record.
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?
biliary events (time frame: 3 month). 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 17 Mar 2025.