Acute Pancreatitis Due to GallstonesPhase 3OSOPOLARNCT04924868
Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
A Phase 3 study testing Ursodeoxycholic Acid in people with Acute Pancreatitis Due to Gallstones, run by Hospital General Universitario de Alicante at 18 sites in Spain.
Trial summary
Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis Due to Gallstones
- What is being tested?
- Ursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 18 sitesSpain
- Study dates
- 10 Nov 2021to 1 Jul 2027
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Hospital admission due to acute pancreatitis (definition: at least 2 of the following criteria: A) Typical pancreatitis pain, B) Amylase and/or lipase higher than 3 times the upper level of normality, C) Imaging compatible with acute pancreatitis
- Presence of gallstones according to any imaging technique
- Patient informed consent
Who cannot join
- Cholecystectomy and/or endoscopic retrograde cholangio-pancreatography and / or endoscopic cholecystostomy prior to recruitment
- Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)
- Current waiting list for cholecystectomy for acute biliary pancreatitis at that center less than 30 days
- Randomization more than 3 days after hospital discharge for acute pancreatitis
- Ursodeoxycholic acid (UDCA) consumption in the last 5 years or previous UDCA failure to dissolve lithiasis
- Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with active gastric or duodenal ulcer, liver or intestinal disorders that interfere with the enterohepatic circulation of bile salts and lactation)
Show all 15Show fewer
- Presence of choledocholithiasis diagnosed by imaging tests prior to randomization
- Active alcoholism greater than or equal to 5 daily alcoholic drinks in men or 3 in women or high clinical suspicion of clinically significant alcoholism
- Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult
- Hypertriglyceridemia greater than 400 mg / dL during admission or history of poorly controlled severe hypertriglyceridemia
- Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct 4 or more mm)
- Pancreatic cystic lesions not attributed to the pancreatitis itself
- Wirsung duct stenosis
- Primary hyperparathyroidism
- Pregnancy
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Spain18 sites, 18 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Alicia Vaillo, 0034 661302932, vailloalicia@gmail.com
Enrique de Madaria, Medicine
- Recruiting
Hospital Clínico Universitario de Valencia
Alicante, Valencia, 46010
Isabel Pascual Moreno, Medicine, isabel.pascual-moreno@uv.es
Isabel Pascual Moreno, Medicine
- Not yet recruiting
Hospital Univerisitario Vall D´Hebron
Barcelona, Barcelona, 08035
Francesc Xa Molero Richard, Medicine, xavier.molero@vhir.org
Francesc Xa Molero Richard, Medicine
- Recruiting
Hospital Universitario de Cruces
Bilbao, Vizcaya, 48903
Emma Martínez Moneo, EMMA.MARTINEZMONEO@osakidetza.eus
Emma Martínez Moneo, Medicine
- Not yet recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Irene Pascual Sánchez, irenepascuals@gmail.com
Irene Pascual Sánchez, Medicine
- Not yet recruiting
Hospital Clínio San Cecilio
Granada, Granada, 18016
Antonio M Caballero, Medicine, ogy1492@hotmail.com
Antonio M Caballero, Medicine
- Not yet recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Silvia Salord Vila, Medicine, ssalord@bellvitgehospital.cat
Silvia Salord Vila, Medicine
- Recruiting
Hospital Ramon y Cajal
Madrid, Madrid
Ana García García De Paredes, Medicine, anaggparedes@gmail.com
Ana García García de Paredes
- Recruiting
Hospital Costa del Sol,
Marbella, Málaga, 29603
Robin Rivera Irigoin, Medicine, robinriverai@yahoo.es
Robin Rivera Irigoin, Medicine
- Not yet recruiting
Complejo Hospitalario de Ourense
Ourense, Ourense, 32005
Maria Francisco González, mariamedico@hotmail.com
Maria Francisco González, Medicine
- Recruiting
Hospital Universitario Central de Asturias.
Oviedo, Principality of Asturias, 33011
Maria Eu Lauret Braña, meugelb@hotmail.com
Maria Eu Lauret Braña, Medicine
- Recruiting
Clinica Unversidad de Navarra
Pamplona, Navarre, 31008
Cristina Carretero Ribón, Medicine, ccarretero@unav.es
Cristina Carretero Ribón, Medicine
- Not yet recruiting
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, 08208
Laura Pa Llovet Soto, Medicine, laura.llovet@gmail.com
Laura Pa Llovet Soto, Medicine
- Not yet recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Claudia Sánchez Marín, claudiasanchez370@gmail.com
Claudia Sánchez Marín, Medicine
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A coruña, 15706
Juan En Domínguez Muñoz, Medicine, juanenrique.dominguez@usc.es
Juan En Domínguez Muñoz
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Maria Lo Ruíz Rebollo, 983 42 00 00, mlruizr@saludcastillayleon.es
Maria Lo Ruíz Rebollo
- Recruiting
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009
Guillermo García Rayado, Medicine, guillermogarcia7@hotmail.com
Guillermo García Rayado, Medicine
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
Vanesa Bernal Monterde, vbernalm@gmail.com
Vanesa Bernal Monterde, Medicine
About this study
Official title: Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial
Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. The risk of suffering another acute biliary pancreatitis (ABP, that is to say, pancreatitis due to gallstones) or of other biliary complications in the following weeks or months is high (20% or greater) if measures are not taken to avoid it, being surgical removal of the gallbladder the most effective. Unfortunately, most Spanish centers have a surgical waiting list that makes gallbladder surgery unfeasible in a period of less than weeks or months, which is why readmission for biliary problems derived from the stones is a common problem. This, of course, causes danger and great stress and anger for patients affected by these complications on the waiting list, damaging their relationship with the health system and it is linked to increased cost. In addition, there is a very vulnerable group, those patients who due to age or serious diseases cannot undergo gallbladder surgery but have a high probability of suffering biliary problems due to the stones they have.
Ursodeoxycholic acid (UDCA) is very safe drug which is used to dissolve gallstones, but its role in preventing biliary complications after ABP has not been studied adequately so it is not frequently used. Our objective is to investigate if UDCA is useful in this scenario, which would avoid suffering and adverse consequences for the patient and reduce the consumption of resources.
- Conditions
- Acute Pancreatitis Due to Gallstones
- Being tested
- Ursodeoxycholic Acid, Placebo
- Keywords
- Acute pancreatitis, Gallstones, Ursodeoxycholic Acid, Randomized Controlled Trial
- Medical subject headings
- Pancreatitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic AcidDrug
Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones
PlaceboDrug
Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g.
| Study group | Role | What they receive |
|---|---|---|
| UDCA (Ursodeoxycholic Acid) group | Active comparator | Patients receiving Ursodeoxycholic Acid, capsules containing 300 mg, 10 mg/Kg per day:
Patients 40 to 70 kg: 2 capsules/day >70 to 100 Kg: 3 capsules/day >100 kg: 4 capsules/day Receives: Drug: Ursodeoxycholic Acid |
| Placebo group | Placebo comparator | Capsules containing placebo, indistinguishable from active treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication due to gallstones
Composite endpoint: incidence of any of the following: acute pancreatitis, acute cholangitis, acute cholecystitis, biliary colic (with or without choledocholithiasis) Definitions are provided in "Secondary Outcome Measures"
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Secondary outcomes (17)
Relapse of acute pancreatitis
New episode of acute pancreatitis after recruitment Definition of acute pancreatitis (revised Atlanta classification): 2 or more of the following criteria: A) Typical pancreatitis pain, B) Amylase and/or lipase higher than 3 times the upper level of normality, C) Imaging compatible with acute pancreatitis
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of acute cholangitis
Acute cholangitis after recruitment
Acute cholangitis definition (Tokyo 2018 guidelines):
- Systemic inflammation: A-1. Fever and/or shaking chills; A-2. Laboratory data: evidence of inflammatory response B. Cholestasis: B-1. Jaundice; B-2. Laboratory data: abnormal liver function tests C. Imaging: C-1. Biliary dilatation; C-2. Evidence of the etiology on imaging (stricture, stone, stent etc.) Suspected diagnosis: one item in A + one item in either B or C Definite diagnosis: one item in A, one item in B and one item in C
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of acute cholecystitis
Acute cholecystitis after recruitment
Acute cholecystitis definition (Tokyo 2018 guidelines):
- Local signs of inflammation: (1) Murphy's sign, (2) RUQ mass/pain/tenderness B. Systemic signs of inflammation: (1) Fever, (2) elevated CRP, (3) elevated WBC count C. Imaging findings: Imaging findings characteristic of acute cholecystitis Suspected diagnosis: one item in A + one item in B Definite diagnosis: one item in A + one item in B + C
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of biliary colic, with or without choledocholithiasis
Biliary colic after recruitment Biliary colic definition: typical biliary colic pain. Choledocholithiasis: presence of stones or biliary sludge in the common bile duct according to imaging or endoscopic retrograde cholangio-pancreatography
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Effectiveness of ursodeoxycholic acid in treating gallstones
Decrease or elimination of gallstones according to ultrasonography
Measured: Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed
EORTC-QLQ C30 questionnaire
EORTC-QLQ C30 questionnaire as a measure of Quality of Life
Measured: Measurement at 1, 3, 6, 9 and 12 months after recruitment
Hospital stay during follow-up
Number of days admitted due to symptomatic gallstone disease
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Intensive care unit stay during follow-up
Number of days admitted in the intensive care unit due to symptomatic gallstone disease
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Adverse events
Adverse events due to ursodeoxycolic acid or placebo
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease
Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up
Need for ERCP due to choledocholithiasis or acute cholangitis
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for gallbladder endoscopic or percutaneous drainage during follow-up
Need for gallbladder endoscopic or percutaneous drainage due to acute cholecystitis or cholangitis
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for drainage of collections and abscesses
Need for drainage of collections and abscesses (liver abscess, symtomatic pancreatic or peripancreatic collections not related to the index acute pancreatitis)
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of organ failure during follow-up
Organ failure definition (revised Atlanta classification): PaO2/FIO2<300, Creatinine >=1.9 mg/dl and/or systolic blood pressure <90mmHg despite fluid resuscitation
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Mortality
Death during follow-up
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for urgent cholecystectomy
Need for urgent cholecystectomy for acute gallbladder complication, mainly acute cholecystitis
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for surgical necrosectomy
Need for surgical necrosectomy, mainly after infection of pancreatic necrosis (not related to the index acute pancreatitis)
Measured: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start10 Nov 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis Due to GallstonesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Enrique de-Madaria, Hospital General Universitario de Alicante
- Investigators
- Enrique De Madaria, Medicine, Principal investigator, Alicante General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924868
- Sponsor's protocol ID
- 2020/159
- Other IDs
- 2020-005901-16
- Acronym
- OSOPOLAR
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2021
- Last updated
- 20 Mar 2025
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial
- ClinicalTrials.gov ID
- NCT04924868
- Acronym / sponsor ID
- OSOPOLAR / 2020/159
- Conditions
- Acute Pancreatitis Due to Gallstones
- Keywords
- Acute pancreatitis, Gallstones, Ursodeoxycholic Acid, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Jun 2021 (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.
Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. The risk of suffering another acute biliary pancreatitis (ABP, that is to say, pancreatitis due to gallstones) or of other biliary complications in the following weeks or months is high (20% or greater) if measures are not taken to avoid it, being surgical removal of the gallbladder the most effective. Unfortunately, most Spanish centers have a surgical waiting list that makes gallbladder surgery unfeasible in a period of less than weeks or months, which is why readmission for biliary problems derived from the stones is a common problem. This, of course, causes danger and great stress and anger for patients affected by these complications on the waiting list, damaging their relationship with the health system and it is linked to increased cost. In addition, there is a very vulnerable group, those patients who due to age or serious diseases cannot undergo gallbladder surgery but have a high probability of suffering biliary problems due to the stones they have.
Ursodeoxycholic acid (UDCA) is very safe drug which is used to dissolve gallstones, but its role in preventing biliary complications after ABP has not been studied adequately so it is not frequently used. Our objective is to investigate if UDCA is useful in this scenario, which would avoid suffering and adverse consequences for the patient and reduce the consumption of resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDCA (Ursodeoxycholic Acid) group | Active comparator | Drug: Ursodeoxycholic AcidPatients receiving Ursodeoxycholic Acid, capsules containing 300 mg, 10 mg/Kg per day: Patients 40 to 70 kg: 2 capsules/day >70 to 100 Kg: 3 capsules/day >100 kg: 4 capsules/day |
| Placebo group | Placebo comparator | Drug: PlaceboCapsules containing placebo, indistinguishable from active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Hospital admission due to acute pancreatitis (definition: at least 2 of the following criteria: A) Typical pancreatitis pain, B) Amylase and/or lipase higher than 3 times the upper level of normality, C) Imaging compatible with acute pancreatitis
- Presence of gallstones according to any imaging technique
- Patient informed consent
Key exclusion criteria (15 listed)
- Cholecystectomy and/or endoscopic retrograde cholangio-pancreatography and / or endoscopic cholecystostomy prior to recruitment
- Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)
- Current waiting list for cholecystectomy for acute biliary pancreatitis at that center less than 30 days
- Randomization more than 3 days after hospital discharge for acute pancreatitis
- Ursodeoxycholic acid (UDCA) consumption in the last 5 years or previous UDCA failure to dissolve lithiasis
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 |
|---|---|---|
| Ursodeoxycholic AcidUrsodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones | Drug | UDCA (Ursodeoxycholic Acid) group |
| PlaceboPlacebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g. | Drug | Placebo group |
Primary outcome
Complication due to gallstones
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Composite endpoint: incidence of any of the following: acute pancreatitis, acute cholangitis, acute cholecystitis, biliary colic (with or without choledocholithiasis) Definitions are provided in "Secondary Outcome Measures"
17 secondary outcomes
Relapse of acute pancreatitis
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of acute cholangitis
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of acute cholecystitis
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of biliary colic, with or without choledocholithiasis
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Effectiveness of ursodeoxycholic acid in treating gallstones
Time frame: Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed
EORTC-QLQ C30 questionnaire
Time frame: Measurement at 1, 3, 6, 9 and 12 months after recruitment
Hospital stay during follow-up
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Intensive care unit stay during follow-up
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Adverse events
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for gallbladder endoscopic or percutaneous drainage during follow-up
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for drainage of collections and abscesses
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of organ failure during follow-up
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Mortality
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for urgent cholecystectomy
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for surgical necrosectomy
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
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 20 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Pancreatitis Due to Gallstones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
Enrolling by invitation
PrEveNtion of Biliary Events After Acute Pancreatitis in NonSUrgicaL PAtients: PENINSULA Trial
Acute Pancreatitis Due to Gallstones, Acute Pancreatitis
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.
Enrique De Madaria, Medicine principal investigator
Alicante General University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ursodeoxycholic Acid in people with Acute Pancreatitis Due to Gallstones, run by Hospital General Universitario de Alicante at 18 sites in Spain.
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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 20 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 18 sites in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Alicia Vaillo ((+34) 661302932, vailloalicia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication due to gallstones (time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed). 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 20 Mar 2025.