Biliary Candidiasis - Optimization of Diagnostics and Therapy

NCT01109550 | Completed

• 1 other identifier: BILIARY-CANDIDIASIS_2010
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Biliary obstruction and cholangitis are common problems in gastroenterology and need specific therapeutic interventions. Besides a variety of potential causes, infections of the biliary tract with Candida and other fungal species have increasingly been reported in the last few years. Especially interesting is the question, if patients with positive fungal cultures of bile samples should be treated or not and under which circumstances. The primary aim of the present study is to evaluate wether positive fungal cultures of bile samples indicate fungal infection of the biliary tract, rather colonization or simply contamination during endoscopic retrograde cholangiopancreatography (ERCP) procedure.

Conditions

Secondary Cholangitis; Bile Duct Strictures of Unknown Origin

Outcome Measures

Primary Outcomes (1)

• Diagnosis of an invasive fungal infection of the biliary tract

  Diagnosis of an invasive fungal infection of the biliary tract

  12 month

Secondary Outcomes (1)

• Evaluation of risk factors 2. Implementation of an algorithm in diagnostics and therapy

  12 month

Study Arms (2)

with biliary candidiasis

Patients with positive fungal cultures of bile samples.

Procedure: ERCP

without biliary candidiasis

Patients with negative fungal cultures of bile samples.

Procedure: ERCP

Interventions

ERCP PROCEDURE

endoscopic retrograde cholangiopancreatography transpapillary biopsies

with biliary candidiasis; without biliary candidiasis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to a hospital of maximum care.

You may qualify if:

• Secondary cholangitis
• Bile duct strictures of unknown origin
• Age ≥ 18 years
• All individuals provide written informed consent before entering the trial

You may not qualify if:

• Ineffective aspiration of bile samples
• Pregnant or breastfeeding patient
• Age \< 18 years
• Missing informed consent
• Missing cooperation (language barrier, amblyacousia, psychiatric disease)
• Refusal of participation

Sponsors & Collaborators

• University Hospital Muenster: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Unitersity Hospital of Muenster, Department of Medicine B

Münster, 48149, Germany

Location

Related Publications (13)

• Banerjee SN, Emori TG, Culver DH, Gaynes RP, Jarvis WR, Horan T, Edwards JR, Tolson J, Henderson T, Martone WJ. Secular trends in nosocomial primary bloodstream infections in the United States, 1980-1989. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):86S-89S. doi: 10.1016/0002-9343(91)90349-3.

  PMID: 1928197 BACKGROUND

• Bouche H, Housset C, Dumont JL, Carnot F, Menu Y, Aveline B, Belghiti J, Boboc B, Erlinger S, Berthelot P, et al. AIDS-related cholangitis: diagnostic features and course in 15 patients. J Hepatol. 1993 Jan;17(1):34-9. doi: 10.1016/s0168-8278(05)80518-5.

  PMID: 8445217 BACKGROUND

• Domagk D, Fegeler W, Conrad B, Menzel J, Domschke W, Kucharzik T. Biliary tract candidiasis: diagnostic and therapeutic approaches in a case series. Am J Gastroenterol. 2006 Nov;101(11):2530-6. doi: 10.1111/j.1572-0241.2006.00663.x. Epub 2006 Oct 4.

  PMID: 17029620 BACKGROUND

• George J, Baillie J. Contemporary Management of Biliary Tract Infections. Curr Infect Dis Rep. 2005 Mar;7(2):108-114. doi: 10.1007/s11908-005-0069-y.

  PMID: 15727737 BACKGROUND

• Singh N, Wagener MM, Marino IR, Gayowski T. Trends in invasive fungal infections in liver transplant recipients: correlation with evolution in transplantation practices. Transplantation. 2002 Jan 15;73(1):63-7. doi: 10.1097/00007890-200201150-00011.

  PMID: 11792979 BACKGROUND

• Wig JD, Singh K, Chawla YK, Vaiphei K. Cholangitis due to candidiasis of the extra-hepatic biliary tract. HPB Surg. 1998;11(1):51-4. doi: 10.1155/1998/75730.

  PMID: 9830582 BACKGROUND

• Domagk D, Bisping G, Poremba C, Fegeler W, Domschke W, Menzel J. Common bile duct obstruction due to candidiasis. Scand J Gastroenterol. 2001 Apr;36(4):444-6. doi: 10.1080/003655201300051397.

  PMID: 11336173 BACKGROUND

• Lenz P, Conrad B, Kucharzik T, Hilker E, Fegeler W, Ullerich H, Heinecke A, Domschke W, Domagk D. Prevalence, associations, and trends of biliary-tract candidiasis: a prospective observational study. Gastrointest Endosc. 2009 Sep;70(3):480-7. doi: 10.1016/j.gie.2009.01.038. Epub 2009 Jun 24.

  PMID: 19555935 BACKGROUND

• Domagk D, Poremba C, Dietl KH, Senninger N, Heinecke A, Domschke W, Menzel J. Endoscopic transpapillary biopsies and intraductal ultrasonography in the diagnostics of bile duct strictures: a prospective study. Gut. 2002 Aug;51(2):240-4. doi: 10.1136/gut.51.2.240.

  PMID: 12117887 BACKGROUND

• Kubota Y, Takaoka M, Tani K, Ogura M, Kin H, Fujimura K, Mizuno T, Inoue K. Endoscopic transpapillary biopsy for diagnosis of patients with pancreaticobiliary ductal strictures. Am J Gastroenterol. 1993 Oct;88(10):1700-4.

  PMID: 8213710 BACKGROUND

• Sugiyama M, Atomi Y, Wada N, Kuroda A, Muto T. Endoscopic transpapillary bile duct biopsy without sphincterotomy for diagnosing biliary strictures: a prospective comparative study with bile and brush cytology. Am J Gastroenterol. 1996 Mar;91(3):465-7.

  PMID: 8633492 BACKGROUND

• Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Ido K, Sugano K. Endoscopic transpapillary bile duct biopsy with the combination of intraductal ultrasonography in the diagnosis of biliary strictures. Gut. 2002 Mar;50(3):326-31. doi: 10.1136/gut.50.3.326.

  PMID: 11839709 BACKGROUND

• Lenz P, Eckelskemper F, Erichsen T, Lankisch T, Dechene A, Lubritz G, Lenze F, Beyna T, Ullerich H, Schmedt A, Domagk D. Prospective observational multicenter study to define a diagnostic algorithm for biliary candidiasis. World J Gastroenterol. 2014 Sep 14;20(34):12260-8. doi: 10.3748/wjg.v20.i34.12260.

  PMID: 25232260 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

bile samples, buccal smears, stool samples, blood samples, transpapillary biopsies (bile duct)

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Philipp Lenz, M.D.

  University Hospital of Muenster

  STUDY CHAIR

• Dirk Domagk, M.D.

  University Hospital of Muenster

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 28, 2022

Record last verified: 2012-12

Locations

DE (1)