Clinical trial NCT04924868: Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
Official title: Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Pancreatitis Due to Gallstones
Keywords: Acute pancreatitis
Gallstones
Ursodeoxycholic Acid
Randomized Controlled Trial
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-06-14
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Complication due to gallstones
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Secondary outcomes:
measure: Relapse of acute pancreatitis
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Incidence of acute cholangitis
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Incidence of acute cholecystitis
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Incidence of biliary colic, with or without choledocholithiasis
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Effectiveness of ursodeoxycholic acid in treating gallstones
timeFrame: Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed
measure: EORTC-QLQ C30 questionnaire
timeFrame: Measurement at 1, 3, 6, 9 and 12 months after recruitment
measure: Hospital stay during follow-up
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Intensive care unit stay during follow-up
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Adverse events
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Need for gallbladder endoscopic or percutaneous drainage during follow-up
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Need for drainage of collections and abscesses
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Incidence of organ failure during follow-up
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Mortality
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Need for urgent cholecystectomy
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
measure: Need for surgical necrosectomy
timeFrame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: A coruña
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias.
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí de Sabadell
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Marbella
country: Spain
facility: Hospital Costa del Sol,
state: Málaga
city: Pamplona
country: Spain
facility: Clinica Unversidad de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Valencia
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Univerisitario Vall D´Hebron
city: Granada
country: Spain
facility: Hospital Clínio San Cecilio
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Alicante General University Hospital
name: Enrique De Madaria, Medicine
role: PRINCIPAL_INVESTIGATOR
References: