AzTrials
AzTrials

Liver TransplantationNCT00990470

Endoscopic Evaluation in Transplantation Candidates

An observational study of Liver Transplantation, run by Hannover Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Germany1 site
  • Hannover Medical School

    Hanover, 30625

Other trials in Germany

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:

  1. 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?
  2. What is the influence of endoscopic findings on patient management before transplantation?
  3. Which risk factors can be identified that predict the presence of GI-lesions?
  4. Is there a subgroup of patients, in which screening colonoscopy before liver transplantation can not be recommended considering the cost/benefit ratio?
  5. 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.

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.

  1. First posted6 Oct 2009 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in