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Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis (OSOPOLAR)

Primary Purpose

Acute Pancreatitis Due to Gallstones

Status
Not yet recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Ursodeoxycholic Acid
Placebo
Sponsored by
Hospital General Universitario de Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pancreatitis Due to Gallstones focused on measuring Acute pancreatitis, Gallstones, Ursodeoxycholic Acid, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico Universitario de Santiago
  • Hospital General Universitario de Elche
  • Hospital Universitario Central de Asturias.
  • Hospital de Bellvitge
  • Consorci Corporació Sanitària Parc Taulí de Sabadell
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Costa del Sol,
  • Clinica Unversidad de Navarra
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario de Cruces
  • Hospital General Universitario de Alicante
  • Hospital Univerisitario Vall D´Hebron
  • Hospital Clínio San Cecilio
  • Hospital Ramon y Cajal
  • Complejo Hospitalario de Ourense
  • Hospital Clínico Universitario de Valladolid
  • Hospital Clínico Lozano Blesa
  • Hospital Universitario Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

UDCA (Ursodeoxycholic Acid) group

Placebo group

Arm Description

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

Capsules containing placebo, indistinguishable from active treatment.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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
Incidence of acute cholangitis
Acute cholangitis after recruitment Acute cholangitis definition (Tokyo 2018 guidelines): A. 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
Incidence of acute cholecystitis
Acute cholecystitis after recruitment Acute cholecystitis definition (Tokyo 2018 guidelines): A. 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
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
Effectiveness of ursodeoxycholic acid in treating gallstones
Decrease or elimination of gallstones according to ultrasonography
EORTC-QLQ C30 questionnaire
EORTC-QLQ C30 questionnaire as a measure of Quality of Life
Hospital stay during follow-up
Number of days admitted due to symptomatic gallstone disease
Intensive care unit stay during follow-up
Number of days admitted in the intensive care unit due to symptomatic gallstone disease
Adverse events
Adverse events due to ursodeoxycolic acid or placebo
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
Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up
Need for ERCP due to choledocholithiasis or acute cholangitis
Need for gallbladder endoscopic or percutaneous drainage during follow-up
Need for gallbladder endoscopic or percutaneous drainage due to acute cholecystitis or cholangitis
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)
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
Mortality
Death during follow-up
Need for urgent cholecystectomy
Need for urgent cholecystectomy for acute gallbladder complication, mainly acute cholecystitis
Need for surgical necrosectomy
Need for surgical necrosectomy, mainly after infection of pancreatic necrosis (not related to the index acute pancreatitis)

Full Information

First Posted
June 8, 2021
Last Updated
June 8, 2021
Sponsor
Hospital General Universitario de Alicante
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT04924868
Brief Title
Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
Acronym
OSOPOLAR
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario de Alicante
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis Due to Gallstones
Keywords
Acute pancreatitis, Gallstones, Ursodeoxycholic Acid, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UDCA (Ursodeoxycholic Acid) group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Capsules containing placebo, indistinguishable from active treatment.
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Intervention Description
Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g.
Primary Outcome Measure Information:
Title
Complication due to gallstones
Description
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"
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Secondary Outcome Measure Information:
Title
Relapse of acute pancreatitis
Description
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
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Incidence of acute cholangitis
Description
Acute cholangitis after recruitment Acute cholangitis definition (Tokyo 2018 guidelines): A. 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
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Incidence of acute cholecystitis
Description
Acute cholecystitis after recruitment Acute cholecystitis definition (Tokyo 2018 guidelines): A. 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
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Incidence of biliary colic, with or without choledocholithiasis
Description
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
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Effectiveness of ursodeoxycholic acid in treating gallstones
Description
Decrease or elimination of gallstones according to ultrasonography
Time Frame
Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed
Title
EORTC-QLQ C30 questionnaire
Description
EORTC-QLQ C30 questionnaire as a measure of Quality of Life
Time Frame
Measurement at 1, 3, 6, 9 and 12 months after recruitment
Title
Hospital stay during follow-up
Description
Number of days admitted due to symptomatic gallstone disease
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Intensive care unit stay during follow-up
Description
Number of days admitted in the intensive care unit due to symptomatic gallstone disease
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Adverse events
Description
Adverse events due to ursodeoxycolic acid or placebo
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease
Description
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
Title
Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up
Description
Need for ERCP due to choledocholithiasis or acute cholangitis
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Need for gallbladder endoscopic or percutaneous drainage during follow-up
Description
Need for gallbladder endoscopic or percutaneous drainage due to acute cholecystitis or cholangitis
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Need for drainage of collections and abscesses
Description
Need for drainage of collections and abscesses (liver abscess, symtomatic pancreatic or peripancreatic collections not related to the index acute pancreatitis)
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Incidence of organ failure during follow-up
Description
Organ failure definition (revised Atlanta classification): PaO2/FIO2<300, Creatinine >=1.9 mg/dl and/or systolic blood pressure <90mmHg despite fluid resuscitation
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Mortality
Description
Death during follow-up
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Need for urgent cholecystectomy
Description
Need for urgent cholecystectomy for acute gallbladder complication, mainly acute cholecystitis
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Title
Need for surgical necrosectomy
Description
Need for surgical necrosectomy, mainly after infection of pancreatic necrosis (not related to the index acute pancreatitis)
Time Frame
From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Vaillo
Phone
(+34) 661302932
Email
vailloalicia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique De Madaria, Medicine
Organizational Affiliation
Alicante General University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan En Domínguez Muñoz, Medicine
Email
juanenrique.dominguez@usc.es
First Name & Middle Initial & Last Name & Degree
Juan En Domínguez Muñoz
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Pascual Sánchez
Email
irenepascuals@gmail.com
First Name & Middle Initial & Last Name & Degree
Irene Pascual Sánchez, Medicine
Facility Name
Hospital Universitario Central de Asturias.
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Eu Lauret Braña
Email
meugelb@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maria Eu Lauret Braña, Medicine
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Salord Vila, Medicine
Email
ssalord@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Silvia Salord Vila, Medicine
Facility Name
Consorci Corporació Sanitària Parc Taulí de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Pa Llovet Soto, Medicine
Email
laura.llovet@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Pa Llovet Soto, Medicine
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Sánchez Marín
Email
claudiasanchez370@gmail.com
First Name & Middle Initial & Last Name & Degree
Claudia Sánchez Marín, Medicine
Facility Name
Hospital Costa del Sol,
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Rivera Irigoin, Medicine
Email
robinriverai@yahoo.es
First Name & Middle Initial & Last Name & Degree
Robin Rivera Irigoin, Medicine
Facility Name
Clinica Unversidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Carretero Ribón, Medicine
Email
ccarretero@unav.es
First Name & Middle Initial & Last Name & Degree
Cristina Carretero Ribón, Medicine
Facility Name
Hospital Clínico Universitario de Valencia
City
Alicante
State/Province
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Pascual Moreno, Medicine
Email
isabel.pascual-moreno@uv.es
First Name & Middle Initial & Last Name & Degree
Isabel Pascual Moreno, Medicine
Facility Name
Hospital Universitario de Cruces
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Martínez Moneo
Email
EMMA.MARTINEZMONEO@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Emma Martínez Moneo, Medicine
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Vaillo
Phone
0034 661302932
Email
vailloalicia@gmail.com
First Name & Middle Initial & Last Name & Degree
Enrique de Madaria, Medicine
Facility Name
Hospital Univerisitario Vall D´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesc Xa Molero Richard, Medicine
Email
xavier.molero@vhir.org
First Name & Middle Initial & Last Name & Degree
Francesc Xa Molero Richard, Medicine
Facility Name
Hospital Clínio San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio M Caballero, Medicine
Email
ogy1492@hotmail.com
First Name & Middle Initial & Last Name & Degree
Antonio M Caballero, Medicine
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana García García De Paredes, Medicine
Email
anaggparedes@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana García García de Paredes
Facility Name
Complejo Hospitalario de Ourense
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Francisco González
Email
mariamedico@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maria Francisco González, Medicine
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo García Rayado, Medicine
Email
guillermogarcia7@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guillermo García Rayado, Medicine
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanesa Bernal Monterde
Email
vbernalm@gmail.com
First Name & Middle Initial & Last Name & Degree
Vanesa Bernal Monterde, Medicine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis

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