Liver TransplantationNCT00990470
Endoscopic Evaluation in Transplantation Candidates
An observational study of Liver Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
In consideration of the limited supply of donor organs, the careful selection of transplant candidates is essential to optimize patient outcome after transplantation. Therefore an extensive evaluation of transplant candidates including among others esophagogastroduodenoscopy (EGD) and colonoscopy has been implemented… Read more about this study
- Who is it for?
- Ages 1 day to 80 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Dec 2010
- 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 1 day to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients evaluated for Tranplantation at Hannover Medical School
Who may be able to join
- Patients who receive upper and/or lower endoscopy during evaluation for transplantation
Who cannot join
- patient already on waiting list
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Evaluation in Transplantation Candidates - Frequency and Prognostic Relevance of Upper and Lower Gastrointestinal Tract Findings
In consideration of the limited supply of donor organs, the careful selection of transplant candidates is essential to optimize patient outcome after transplantation. Therefore an extensive evaluation of transplant candidates including among others esophagogastroduodenoscopy (EGD) and colonoscopy has been implemented in our centre. The data regarding the prevalence of upper and lower gastrointestinal (GI) pathology in transplant candidates are contradictory and are based on only a few retrospective studies, which often include only a subgroup of transplant candidates. The goal of this project is a prospective evaluation of the frequency of GI pathologies in transplant candidates with specific focus on the following questions:
- Are there GI-pathologies that occur at a higher prevalence in transplant candidates than described in the general population and is there an increase of GI-pathologies since the introduction of the urgency-based organ allocation leading to sicker transplant candidates?
- What is the influence of endoscopic findings on patient management before transplantation?
- Which risk factors can be identified that predict the presence of GI-lesions?
- Is there a subgroup of patients, in which screening colonoscopy before liver transplantation can not be recommended considering the cost/benefit ratio?
- Is there a correlation of endoscopic findings with outcome after liver transplantation or with gastrointestinal complications during or after transplantation (e.g. gastrointestinal bleeding, perforation or gastrointestinal malignancy)?
Read the detailed description
Background:
The introduction of a MELD (model for end-stage liver disease) based necessity-oriented allocation system for liver transplantation (OLT) has lead to an increasing number of patients with advanced liver disease on the waiting list. Hence it is essential to optimize outcome after transplantation in this high-risk patient collective in order to best utilize the limited supply of donor organs. To achieve this goal, the careful selection of appropriate transplantation candidates is based on an extensive evaluation of the patients including cardiac, pulmonary and renal testing and different imaging methods to exclude malignancies or an infective focus. As in many other institutions also in the Medical School Hannover (MHH) esophagogastroduodenoscopy (EGD) and colonoscopy are standard procedures during evaluation for liver transplantation. The rationale to perform these procedures is to identify patients with medical conditions that might limit their outcome after OLT. Some endoscopic findings as for example esophageal varices, gastric or duodenal ulcer or colon adenoma can be treated before transplantation, so that the patient enters the waiting list in a better medical condition. If gastrointestinal malignancies are detected, the patient will no longer be considered a candidate for OLT, unless curative treated. The detection of premalignant changes (high grade adenomas, barrett's esophagus etc.) is of great importance, since the immunosuppressed liver transplantation recipients are probably at a higher risk to progress to malignancy.
So far the data regarding the prevalence of upper and lower gastrointestinal pathologies in transplantation candidates are contradictory and are based on only a few retrospective studies. These studies often include only a subgroup of transplantation candidates. Many centres perform screening colonoscopy during OLT evaluation only in patients greater than age 45 or 50, although until today there is no clear evidence, that younger patients do not have a benefit from screening colonoscopy.
So far it is not known if certain preoperative endoscopic findings correlate with postoperative gastrointestinal complications. Such a correlation, e.g. between diverticulosis and postoperative colon perforation or peritonitis due to diverticulitis, could be highly relevant for patient management before and after OLT.
Methods:
After signing informed consent the results of EGD and colonoscopy of all patients evaluated for OLT at the MHH together with laboratory and clinical data will be entered in a database. After follow up for at least one year these data will be analyzed. Descriptive statistics as well as a multivariate analysis will be performed, to find out the frequency of endoscopic diagnoses in transplantation candidates and to look for correlations between these findings and patient outcome after OLT.
- Conditions
- Liver Transplantation
- Keywords
- Transplantation, Liver, Endoscopy, Colonoscopy, Gastroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startFeb 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias J. Weismueller, Hannover Medical School
- Investigators
- Jochen Wedemeyer, MD, Principal investigator, MHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990470
- Sponsor's protocol ID
- MHH-Endo-1009
- Status last verified
- Oct 2011
- First submitted
- 5 Oct 2009
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Weismuller TJ, Bleich F, Negm AA, Schneider A, Lankisch TO, Manns MP, Strassburg CP, Wedemeyer J. Screening colonoscopy in liver transplant candidates: risks and findings. Clin Transplant. 2013 Mar-Apr;27(2):E161-8. doi: 10.1111/ctr.12083. Epub 2013 Feb 6.
PubMed 23383749
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Evaluation in Transplantation Candidates - Frequency and Prognostic Relevance of Upper and Lower Gastrointestinal Tract Findings
- ClinicalTrials.gov ID
- NCT00990470
- Acronym / sponsor ID
- MHH-Endo-1009
- Conditions
- Liver Transplantation
- Keywords
- Transplantation, Liver, Endoscopy, Colonoscopy, Gastroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Oct 2009 (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.
In consideration of the limited supply of donor organs, the careful selection of transplant candidates is essential to optimize patient outcome after transplantation. Therefore an extensive evaluation of transplant candidates including among others esophagogastroduodenoscopy (EGD) and colonoscopy has been implemented in our centre. The data regarding the prevalence of upper and lower gastrointestinal (GI) pathology in transplant candidates are contradictory and are based on only a few retrospective studies, which often include only a subgroup of transplant candidates. The goal of this project is a prospective evaluation of the frequency of GI pathologies in transplant candidates with specific focus on the following questions:
- Are there GI-pathologies that occur at a higher prevalence in transplant candidates than described in the general population and is there an increase of GI-pathologies since the introduction of the urgency-based organ allocation leading to sicker transplant candidates?
- What is the influence of endoscopic findings on patient management before transplantation?
- Which risk factors can be identified that predict the presence of GI-lesions?
- Is there a subgroup of patients, in which screening colonoscopy before liver transplantation can not be recommended considering the cost/benefit ratio?
- Is there a correlation of endoscopic findings with outcome after liver transplantation or with gastrointestinal complications during or after transplantation (e.g. gastrointestinal bleeding, perforation or gastrointestinal malignancy)?
Detailed description
Background:
The introduction of a MELD (model for end-stage liver disease) based necessity-oriented allocation system for liver transplantation (OLT) has lead to an increasing number of patients with advanced liver disease on the waiting list. Hence it is essential to optimize outcome after transplantation in this high-risk patient collective in order to best utilize the limited supply of donor organs. To achieve this goal, the careful selection of appropriate transplantation candidates is based on an extensive evaluation of the patients including cardiac, pulmonary and renal testing and different imaging methods to exclude malignancies or an infective focus. As in many other institutions also in the Medical School Hannover (MHH) esophagogastroduodenoscopy (EGD) and colonoscopy are standard procedures during evaluation for liver transplantation. The rationale to perform these procedures is to identify patients with medical conditions that might limit their outcome after OLT. Some endoscopic findings as for example esophageal varices, gastric or duodenal ulcer or colon adenoma can be treated before transplantation, so that the patient enters the waiting list in a better medical condition. If gastrointestinal malignancies are detected, the patient will no longer be considered a candidate for OLT, unless curative treated. The detection of premalignant changes (high grade adenomas, barrett's esophagus etc.) is of great importance, since the immunosuppressed liver transplantation recipients are probably at a higher risk to progress to malignancy.
So far the data regarding the prevalence of upper and lower gastrointestinal pathologies in transplantation candidates are contradictory and are based on only a few retrospective studies. These studies often include only a subgroup of transplantation candidates. Many centres perform screening colonoscopy during OLT evaluation only in patients greater than age 45 or 50, although until today there is no clear evidence, that younger patients do not have a benefit from screening colonoscopy.
So far it is not known if certain preoperative endoscopic findings correlate with postoperative gastrointestinal complications. Such a correlation, e.g. between diverticulosis and postoperative colon perforation or peritonitis due to diverticulitis, could be highly relevant for patient management before and after OLT.
Methods:
After signing informed consent the results of EGD and colonoscopy of all patients evaluated for OLT at the MHH together with laboratory and clinical data will be entered in a database. After follow up for at least one year these data will be analyzed. Descriptive statistics as well as a multivariate analysis will be performed, to find out the frequency of endoscopic diagnoses in transplantation candidates and to look for correlations between these findings and patient outcome after OLT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients evaluated for Tranplantation at Hannover Medical School
Key inclusion criteria (1 listed)
- Patients who receive upper and/or lower endoscopy during evaluation for transplantation
Key exclusion criteria (1 listed)
- patient already on waiting list
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
Not reported in the source record.
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 10 Oct 2011.
- Derived from this study: PubMed 23383749Weismuller TJ, Bleich F, Negm AA, Schneider A, Lankisch TO, Manns MP, Strassburg CP, Wedemeyer J. Screening colonoscopy in liver transplant candidates: risks and findings. Clin Transplant. 2013 Mar-Apr;27(2):E161-8. doi: 10.1111/ctr.12083. Epub 2013 Feb 6.
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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.
Jochen Wedemeyer, MD principal investigator
MHH
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 Liver Transplantation, run by Hannover Medical School 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 1 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 10 Oct 2011. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00990470, which also lists 1 linked publication.
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 10 Oct 2011.