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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005901-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Placebo group | Placebo Comparator | Capsules containing placebo, indistinguishable from active treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic Acid | Drug | Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones |
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| Measure | Description | Time Frame |
|---|---|---|
| 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" | From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia Vaillo | Contact | (+34) 661302932 | vailloalicia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Enrique De Madaria, Medicine | Alicante General University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago | Not yet recruiting | Santiago de Compostela | A coruña | 15706 | Spain |
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| Placebo | Drug | Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g. |
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| 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 | 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): 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed |
| Mortality | Death during follow-up | 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 | 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) | From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed |
| Hospital General Universitario de Alicante | Recruiting | Alicante | Alicante | 03010 | Spain |
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| Hospital General Universitario de Elche | Not yet recruiting | Elche | Alicante | 03203 | Spain |
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| Hospital Univerisitario Vall D´Hebron | Not yet recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Hospital de Bellvitge | Not yet recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| Consorci Corporació Sanitària Parc Taulí de Sabadell | Not yet recruiting | Sabadell | Barcelona | 08208 | Spain |
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| Hospital Universitario Marqués de Valdecilla | Not yet recruiting | Santander | Cantabria | 39008 | Spain |
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| Hospital Clínio San Cecilio | Not yet recruiting | Granada | Granada | 18016 | Spain |
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| Hospital Ramon y Cajal | Recruiting | Madrid | Madrid | Spain |
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| Hospital Costa del Sol, | Recruiting | Marbella | Málaga | 29603 | Spain |
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| Clinica Unversidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| Complejo Hospitalario de Ourense | Not yet recruiting | Ourense | Ourense | 32005 | Spain |
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| Hospital Universitario Central de Asturias. | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
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| Hospital Clínico Universitario de Valencia | Recruiting | Alicante | Valencia | 46010 | Spain |
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| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Valladolid | 47003 | Spain |
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| Hospital Universitario de Cruces | Recruiting | Bilbao | Vizcaya | 48903 | Spain |
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| Hospital Clínico Lozano Blesa | Recruiting | Zaragoza | Zaragoza | 50009 | Spain |
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| Hospital Universitario Miguel Servet | Not yet recruiting | Zaragoza | Zaragoza | 50009 | Spain |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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