Phase
Condition
Liver Disorders
Liver Disease
Gall Bladder Disorders
Treatment
cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)
cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (24 hours)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with acute cholangitis due to common bile duct stones, benign or malignantdistal biliary obstruction or distal biliary stent dysfunction (only stents in situfor a minimum of 30 days)
ERCP with adequate biliary drainage (all common bile duct stones are removed and/orthere is adequate flow of clear bile with or without a biliary stent(s))
Absence of fever (temperature <38.5°C) or a decrease of body temperature of at least 1°C has occurred within 24 hours after ERCP
Age ≥ 18 years
Written informed consent (IC)
Exclusion
Exclusion Criteria:
Other aetiologies of acute cholangitis (e.g. primary sclerosing cholangitis, (sub)hilar and/or intrahepatic strictures or hilar stents)
A recurrent cholangitis (within 3 months)
Patients with surgically altered anatomy (leading to biliary-enteric anastomosis)
Concomitant pancreatitis, according to International Association ofPancreatology/American Pancreatic Association guidelines.[18] Acute pancreatitis isdiagnosed in case of fulfilment of 2 out of 3 of the following criteria:
Upper abdominal pain
Serum amylase or lipase >3x ULN
Signs of acute pancreatitis on imaging
Concomitant cholecystitis, according to TG18 criteria.[19] Acute cholecystitis issuspected in case one item in A is met and one item in B and C.
A. Local signs of inflammation
A1: Murphy's sign
A2: Right upper quadrant mass/pain/tenderness B. Systemic signs of inflammation
B1: Fever
B2: Elevated C-reactive protein
B3: Elevated WBC count C. Imaging findings characteristic of acute cholecystitis
Concomitant liver abscess
Another additional infectious diagnosis
Admission on an Intensive Care Unit (ICU) at time of randomisation
Use of maintenance antimicrobial therapy
Use of immunosuppressants
Neutropenia
Study Design
Study Description
Connect with a study center
Jeroen Bosch Ziekenhuis
Den Bosch, Brabant 5223 GZ
NetherlandsSite Not Available
Catharina Ziekenhuis
Eindhoven, Brabant 5623 EJ
NetherlandsActive - Recruiting
Elisabeth Tweesteden Ziekenhuis
Tilburg, Brabant 5022 GC
NetherlandsActive - Recruiting
Flevoziekenhuis
Almere, Flevoland 1315 RA
NetherlandsSite Not Available
Medisch Centrum Leeuwarden
Leeuwarden, Friesland 8934 AD
NetherlandsSite Not Available
Rijnstate Ziekenhuis
Arnhem, Gelderland 6815 AD
NetherlandsSite Not Available
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland 6532 SZ
NetherlandsActive - Recruiting
Radboud umc
Nijmegen, Gelderland 6525 GA
NetherlandsActive - Recruiting
Maastricht UMC+
Maastricht, Limburg 6229 HX
NetherlandsSite Not Available
Amsterdam UMC
Amsterdam, Noord Holland 1081 HZ
NetherlandsActive - Recruiting
Amstelland Ziekenhuis
Amstelveen, Noord-Holland 1186 AM
NetherlandsSite Not Available
OLVG
Amsterdam, Noord-Holland 1091 AC
NetherlandsSite Not Available
Spaarne Gasthuis
Hoofddorp, Noord-Holland 2134 TM
NetherlandsSite Not Available
Dijklander Ziekenhuis
Hoorn, Noord-Holland 1624 AR
NetherlandsActive - Recruiting
Zaans Medisch Centrum
Zaandam, Noord-Holland 1502 DV
NetherlandsSite Not Available
Deventer Ziekenhuis
Deventer, Overijssel 7416 SE
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede, Overijssel 7512 KZ
NetherlandsSite Not Available
Isala
Zwolle, Overijssel 8025 AB
NetherlandsActive - Recruiting
Meander MC
Amersfoort, Utrecht 3813 TZ
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein, Utrecht 3435 CM
NetherlandsActive - Recruiting
Reinier de Graaf Gasthuis
Delft, Zuid-Holland 2625 AD
NetherlandsSite Not Available
Haaglanden Medisch Centrum
Den Haag, Zuid-Holland 2512 VA
NetherlandsSite Not Available
Albert Schweitzer Ziekenhuis
Dordrecht, Zuid-Holland 3318 AT
NetherlandsActive - Recruiting
Groene Hart Ziekenhuis
Gouda, Zuid-Holland 2803 HH
NetherlandsSite Not Available
Leids Universitair Medisch Centrum
Leiden, Zuid-Holland 2333 ZA
NetherlandsSite Not Available
Alrijne Ziekenhuis
Leiderdorp, Zuid-Holland 2353 GA
NetherlandsSite Not Available
Erasmus MC
Rotterdam, Zuid-Holland 3015 GD
NetherlandsSite Not Available
Maasstad Ziekenhuis
Rotterdam, Zuid-Holland 3079 DZ
NetherlandsActive - Recruiting
Martini Ziekenhuis
Groningen, 9728 NT
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
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