Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-02 @ 11:11 AM
Study NCT ID:
NCT04924868
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication due to gallstones', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', '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"'}], 'secondaryOutcomes': [{'measure': 'Relapse of acute pancreatitis', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', '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'}, {'measure': 'Incidence of acute cholangitis', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': 'Acute cholangitis after recruitment\n\nAcute cholangitis definition (Tokyo 2018 guidelines):\n\nA. 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'}, {'measure': 'Incidence of acute cholecystitis', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': "Acute cholecystitis after recruitment\n\nAcute cholecystitis definition (Tokyo 2018 guidelines):\n\nA. 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"}, {'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', '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'}, {'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', 'description': 'Decrease or elimination of gallstones according to ultrasonography'}, {'measure': 'EORTC-QLQ C30 questionnaire', 'timeFrame': 'Measurement at 1, 3, 6, 9 and 12 months after recruitment', 'description': 'EORTC-QLQ C30 questionnaire as a measure of Quality of Life'}, {'measure': 'Hospital stay during follow-up', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': 'Number of days admitted due to symptomatic gallstone disease'}, {'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', 'description': 'Number of days admitted in the intensive care unit due to symptomatic gallstone disease'}, {'measure': 'Adverse events', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': 'Adverse events due to ursodeoxycolic acid or placebo'}, {'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', 'description': 'Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease'}, {'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', 'description': 'Need for ERCP due to choledocholithiasis or acute cholangitis'}, {'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', 'description': 'Need for gallbladder endoscopic or percutaneous drainage due to acute cholecystitis or cholangitis'}, {'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', 'description': 'Need for drainage of collections and abscesses (liver abscess, symtomatic pancreatic or peripancreatic collections not related to the index acute pancreatitis)'}, {'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', 'description': 'Organ failure definition (revised Atlanta classification): PaO2/FIO2\\<300, Creatinine \\>=1.9 mg/dl and/or systolic blood pressure \\<90mmHg despite fluid resuscitation'}, {'measure': 'Mortality', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': 'Death during follow-up'}, {'measure': 'Need for urgent cholecystectomy', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': 'Need for urgent cholecystectomy for acute gallbladder complication, mainly acute cholecystitis'}, {'measure': 'Need for surgical necrosectomy', 'timeFrame': 'From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed', 'description': 'Need for surgical necrosectomy, mainly after infection of pancreatic necrosis (not related to the index acute pancreatitis)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute pancreatitis', 'Gallstones', 'Ursodeoxycholic Acid', 'Randomized Controlled Trial'], 'conditions': ['Acute Pancreatitis Due to Gallstones']}, 'descriptionModule': {'briefSummary': '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.\n\nUrsodeoxycholic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* 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\n* Presence of gallstones according to any imaging technique\n* Patient informed consent\n\nExclusion Criteria:\n\n* Cholecystectomy and/or endoscopic retrograde cholangio-pancreatography and / or endoscopic cholecystostomy prior to recruitment\n* Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)\n* Current waiting list for cholecystectomy for acute biliary pancreatitis at that center less than 30 days\n* Randomization more than 3 days after hospital discharge for acute pancreatitis\n* Ursodeoxycholic acid (UDCA) consumption in the last 5 years or previous UDCA failure to dissolve lithiasis\n* 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)\n* Presence of choledocholithiasis diagnosed by imaging tests prior to randomization\n* 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\n* Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult\n* Hypertriglyceridemia greater than 400 mg / dL during admission or history of poorly controlled severe hypertriglyceridemia\n* Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct 4 or more mm)\n* Pancreatic cystic lesions not attributed to the pancreatitis itself\n* Wirsung duct stenosis\n* Primary hyperparathyroidism\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04924868', 'acronym': 'OSOPOLAR', 'briefTitle': 'Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario de Alicante'}, 'officialTitle': 'Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial', 'orgStudyIdInfo': {'id': '2020/159'}, 'secondaryIdInfos': [{'id': '2020-005901-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UDCA (Ursodeoxycholic Acid) group', 'description': 'Patients receiving Ursodeoxycholic Acid, capsules containing 300 mg, 10 mg/Kg per day:\n\nPatients 40 to 70 kg: 2 capsules/day \\>70 to 100 Kg: 3 capsules/day \\>100 kg: 4 capsules/day', 'interventionNames': ['Drug: Ursodeoxycholic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Capsules containing placebo, indistinguishable from active treatment.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ursodeoxycholic Acid', 'type': 'DRUG', 'description': 'Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones', 'armGroupLabels': ['UDCA (Ursodeoxycholic Acid) group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A coruña', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan En Domínguez Muñoz, Medicine', 'role': 'CONTACT', 'email': 'juanenrique.dominguez@usc.es'}, {'name': 'Juan En Domínguez Muñoz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alicia Vaillo', 'role': 'CONTACT', 'email': 'vailloalicia@gmail.com', 'phone': '0034 661302932'}, {'name': 'Enrique de Madaria, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene Pascual Sánchez', 'role': 'CONTACT', 'email': 'irenepascuals@gmail.com'}, {'name': 'Irene Pascual Sánchez, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francesc Xa Molero Richard, Medicine', 'role': 'CONTACT', 'email': 'xavier.molero@vhir.org'}, {'name': 'Francesc Xa Molero Richard, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Univerisitario Vall D´Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Salord Vila, Medicine', 'role': 'CONTACT', 'email': 'ssalord@bellvitgehospital.cat'}, {'name': 'Silvia Salord Vila, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura Pa Llovet Soto, Medicine', 'role': 'CONTACT', 'email': 'laura.llovet@gmail.com'}, {'name': 'Laura Pa Llovet Soto, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consorci Corporació Sanitària Parc Taulí de Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Claudia Sánchez Marín', 'role': 'CONTACT', 'email': 'claudiasanchez370@gmail.com'}, {'name': 'Claudia Sánchez Marín, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '18016', 'city': 'Granada', 'state': 'Granada', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio M Caballero, Medicine', 'role': 'CONTACT', 'email': 'ogy1492@hotmail.com'}, {'name': 'Antonio M Caballero, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínio San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana García García De Paredes, Medicine', 'role': 'CONTACT', 'email': 'anaggparedes@gmail.com'}, {'name': 'Ana García García de Paredes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Robin Rivera Irigoin, Medicine', 'role': 'CONTACT', 'email': 'robinriverai@yahoo.es'}, {'name': 'Robin Rivera Irigoin, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Costa del Sol,', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Carretero Ribón, Medicine', 'role': 'CONTACT', 'email': 'ccarretero@unav.es'}, {'name': 'Cristina Carretero Ribón, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Unversidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '32005', 'city': 'Ourense', 'state': 'Ourense', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Francisco González', 'role': 'CONTACT', 'email': 'mariamedico@hotmail.com'}, {'name': 'Maria Francisco González, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Eu Lauret Braña', 'role': 'CONTACT', 'email': 'meugelb@hotmail.com'}, {'name': 'Maria Eu Lauret Braña, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Central de Asturias.', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '46010', 'city': 'Alicante', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Isabel Pascual Moreno, Medicine', 'role': 'CONTACT', 'email': 'isabel.pascual-moreno@uv.es'}, {'name': 'Isabel Pascual Moreno, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '47003', 'city': 'Valladolid', 'state': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Lo Ruíz Rebollo', 'role': 'CONTACT', 'email': 'mlruizr@saludcastillayleon.es', 'phone': '983 42 00 00'}, {'name': 'Maria Lo Ruíz Rebollo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '48903', 'city': 'Bilbao', 'state': 'Vizcaya', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Emma Martínez Moneo', 'role': 'CONTACT', 'email': 'EMMA.MARTINEZMONEO@osakidetza.eus'}, {'name': 'Emma Martínez Moneo, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Guillermo García Rayado, Medicine', 'role': 'CONTACT', 'email': 'guillermogarcia7@hotmail.com'}, {'name': 'Guillermo García Rayado, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vanesa Bernal Monterde', 'role': 'CONTACT', 'email': 'vbernalm@gmail.com'}, {'name': 'Vanesa Bernal Monterde, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Alicia Vaillo', 'role': 'CONTACT', 'email': 'vailloalicia@gmail.com', 'phone': '(+34) 661302932'}], 'overallOfficials': [{'name': 'Enrique De Madaria, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alicante General University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario de Alicante', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Biliary-Pancreatic Unit.', 'investigatorFullName': 'Enrique de-Madaria', 'investigatorAffiliation': 'Hospital General Universitario de Alicante'}}}}