Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial

Who is this study for? Patients with Acute Pancreatitis Due to Gallstones
What treatments are being studied? Ursodeoxycholic Acid
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Clínico Universitario de Valencia
RECRUITING
Alicante
Hospital General Universitario de Alicante
RECRUITING
Alicante
Hospital Univerisitario Vall D´Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Cruces
RECRUITING
Bilbao
Hospital General Universitario de Elche
NOT_YET_RECRUITING
Elche
Hospital Clínio San Cecilio
NOT_YET_RECRUITING
Granada
Hospital de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Costa del Sol,
RECRUITING
Marbella
Complejo Hospitalario de Ourense
NOT_YET_RECRUITING
Ourense
Hospital Universitario Central de Asturias.
RECRUITING
Oviedo
Clinica Unversidad de Navarra
RECRUITING
Pamplona
Consorci Corporació Sanitària Parc Taulí de Sabadell
NOT_YET_RECRUITING
Sabadell
Hospital Universitario Marqués de Valdecilla
NOT_YET_RECRUITING
Santander
Hospital Clínico Universitario de Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Hospital Clínico Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Alicia Vaillo
vailloalicia@gmail.com
(+34) 661302932
Time Frame
Start Date: 2021-11-10
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 332
Treatments
Active_comparator: UDCA (Ursodeoxycholic Acid) group
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
Placebo_comparator: Placebo group
Capsules containing placebo, indistinguishable from active treatment.
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Hospital General Universitario de Alicante

This content was sourced from clinicaltrials.gov