Primary Sclerosing CholangitisNCT01556412
Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis
An observational study of Primary Sclerosing Cholangitis, run by Tischendorf, Jens, M.D. at 1 site in Germany.
Trial summary
Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically affecting middle aged men and is frequently associated with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy
Who may be able to join
- cholestatic hepatopathy defined by elevation of gamma-GT and alkalic phosphatase and
- elevated pANCA and / or medical history of inflammatory bowel disease
Who cannot join
- sign of significant intrahepatic cholestasis or any other cause of necessity of cholangiography on transabdominal ultrasound
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Department III, University Hospital RWTH Aachen
Aachen, Northrhine-Westfalia, 52074
About this study
Official title: Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically affecting middle aged men and is frequently associated with inflammatory bowel disease. Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography (ERC) or percutaneous liver biopsy are needed when magnetic resonance cholangiopancreaticography remains inconclusive. As these procedures are associated with significant risks for the patient, the goal of this study is to evaluate, if endoscopic ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.
Read the detailed description
Different parameters of the common bile duct (wall thickness and irregularity, irregularity of the common bile duct and enlarged lymph nodes) are measured in patients with cholestatic hepatopathy of unknown causes via endoscopic ultrasound (EUS).
This EUS of the CBD is performed from the bulbar position in the duodenum and at least 5 cm of bile duct had to be visualized to correctly analyze bile duct structure.
Further diagnostic work-up of these patients is performed following current guidelines, and definite diagnosis is compared with results of EUS parameters measured. Thus, diagnostic yield of EUS in patients with suspected PSC is further evaluated.
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- endoscopic ultrasound, primary sclerosing cholangitis, EUS, cholestatic hepatopathy
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic hepatopathy suspicious of PSC | All patients with chronic hepatopathy of unknown origin and a high risk of primary sclerosing cholangitis as the underlying disease for chronic hepatopathy. This group includes all patients with cholestatic hepatopathy (predominantly elevated gamma-glutamyltransferase and alkalic phosphatase) and positive ANCAs (Anti-neutrophil cytoplasmic antibodies) and/or inflammatory bowel disease in medical history. Other explanations of cholestatic hepatopathy (like pancreatic tumor or cholelithiasis) must not be apparent in patients eligible for this study. Furthermore, infection oder extrahepatic cholestasis already proven by laboratory results or percutaneous ultrasound, which make endoscopic retrograde cholangiography necessary, are exclusion criteria in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspicion of PSC in endosonographic ultrasound
Endosonographic ultrasound of the common bile duct
Four different diagnostic parameters evaluated during endosonographic ultrasound are evaluated in predicting primary sclerosing cholangitis:
- Wall thickening ≥ 1.5 mm
- Irregular wall structure of the common bile duct
- Irregular caliber of the common bile duct
- Lymph nodes proven in the perihilar region of at least 10 mm diameter were defined as enlarged.
With 2 of 4 criteria positive, patients were classified as suspected diagnostic PSC by means of EUS.
Measured: From date of endosonographic ultrasound until the date of definite diagnosis of cholestatic hepatopathy, up to 3 months (participants will be followed as outclinic patients in our center for an expected average of 6 weeks until definite diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tischendorf, Jens, M.D.
- Responsible party
- Sponsor
- Investigators
- Jens JW Tischendorf, M.D., Principal investigator, Medical Department III, University Hospital RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556412
- Sponsor's protocol ID
- Ti-EUS
- Status last verified
- Oct 2014
- First submitted
- 11 Mar 2012
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lutz HH, Tischendorf JJ. Management of primary sclerosing cholangitis. World J Hepatol. 2011 Jun 27;3(6):137-41. doi: 10.4254/wjh.v3.i6.137.
PubMed 21860672Kirchner GI, Tischendorf JJ, Bleck J, Wagner S, Caselitz M, Klempnauer J, Manns MP, Gebel M. Perihilar lymph nodes in patients with primary sclerosing cholangitis with and without cholangiocellular carcinoma. Scand J Gastroenterol. 2008;43(11):1366-70. doi: 10.1080/00365520802200002.
PubMed 18609164Mesenas S, Vu C, Doig L, Meenan J. Duodenal EUS to identify thickening of the extrahepatic biliary tree wall in primary sclerosing cholangitis. Gastrointest Endosc. 2006 Mar;63(3):403-8. doi: 10.1016/j.gie.2005.10.040.
PubMed 16500387
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Endoscopic Ultrasound as an Early Diagnostic Tool for Evaluation of Suspected Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT01556412
- Acronym / sponsor ID
- Ti-EUS
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- endoscopic ultrasound, primary sclerosing cholangitis, EUS, cholestatic hepatopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tischendorf, Jens, M.D.
- Study start
- Mar 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically affecting middle aged men and is frequently associated with inflammatory bowel disease. Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography (ERC) or percutaneous liver biopsy are needed when magnetic resonance cholangiopancreaticography remains inconclusive. As these procedures are associated with significant risks for the patient, the goal of this study is to evaluate, if endoscopic ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.
Detailed description
Different parameters of the common bile duct (wall thickness and irregularity, irregularity of the common bile duct and enlarged lymph nodes) are measured in patients with cholestatic hepatopathy of unknown causes via endoscopic ultrasound (EUS).
This EUS of the CBD is performed from the bulbar position in the duodenum and at least 5 cm of bile duct had to be visualized to correctly analyze bile duct structure.
Further diagnostic work-up of these patients is performed following current guidelines, and definite diagnosis is compared with results of EUS parameters measured. Thus, diagnostic yield of EUS in patients with suspected PSC is further evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hepatopathy suspicious of PSC | – | –All patients with chronic hepatopathy of unknown origin and a high risk of primary sclerosing cholangitis as the underlying disease for chronic hepatopathy. This group includes all patients with cholestatic hepatopathy (predominantly elevated gamma-glutamyltransferase and alkalic phosphatase) and positive ANCAs (Anti-neutrophil cytoplasmic antibodies) and/or inflammatory bowel disease in medical history. Other explanations of cholestatic hepatopathy (like pancreatic tumor or cholelithiasis) must not be apparent in patients eligible for this study. Furthermore, infection oder extrahepatic cholestasis already proven by laboratory results or percutaneous ultrasound, which make endoscopic retrograde cholangiography necessary, are exclusion criteria in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a single tertiary clinic center with chronic cholestatic hepatopathy
Key inclusion criteria (2 listed)
- cholestatic hepatopathy defined by elevation of gamma-GT and alkalic phosphatase and
- elevated pANCA and / or medical history of inflammatory bowel disease
Key exclusion criteria (1 listed)
- sign of significant intrahepatic cholestasis or any other cause of necessity of cholangiography on transabdominal ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Suspicion of PSC in endosonographic ultrasound
Time frame: From date of endosonographic ultrasound until the date of definite diagnosis of cholestatic hepatopathy, up to 3 months (participants will be followed as outclinic patients in our center for an expected average of 6 weeks until definite diagnosis)
Endosonographic ultrasound of the common bile duct Four different diagnostic parameters evaluated during endosonographic ultrasound are evaluated in predicting primary sclerosing cholangitis: * Wall thickening ≥ 1.5 mm * Irregular wall structure of the common bile duct * Irregular caliber of the common bile duct * Lymph nodes proven in the perihilar region of at least 10 mm diameter were defined as enlarged. With 2 of 4 criteria positive, patients were classified as suspected diagnostic PSC by means of EUS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Background: PubMed 21860672Lutz HH, Tischendorf JJ. Management of primary sclerosing cholangitis. World J Hepatol. 2011 Jun 27;3(6):137-41. doi: 10.4254/wjh.v3.i6.137.
- Background: PubMed 18609164Kirchner GI, Tischendorf JJ, Bleck J, Wagner S, Caselitz M, Klempnauer J, Manns MP, Gebel M. Perihilar lymph nodes in patients with primary sclerosing cholangitis with and without cholangiocellular carcinoma. Scand J Gastroenterol. 2008;43(11):1366-70. doi: 10.1080/00365520802200002.
- Background: PubMed 16500387Mesenas S, Vu C, Doig L, Meenan J. Duodenal EUS to identify thickening of the extrahepatic biliary tree wall in primary sclerosing cholangitis. Gastrointest Endosc. 2006 Mar;63(3):403-8. doi: 10.1016/j.gie.2005.10.040.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens JW Tischendorf, M.D. principal investigator
Medical Department III, University Hospital RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sclerosing Cholangitis, run by Tischendorf, Jens, M.D. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suspicion of PSC in endosonographic ultrasound (time frame: From date of endosonographic ultrasound until the date of definite diagnosis of cholestatic hepatopathy, up to 3 months (participants will be followed as outclinic patients in our center for an expected average of 6 weeks until definite diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.