NCT00990470

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 10, 2011

Status Verified

October 1, 2011

Enrollment Period

4.8 years

First QC Date

October 5, 2009

Last Update Submit

October 7, 2011

Conditions

Keywords

TransplantationLiverEndoscopyColonoscopyGastroscopy

Eligibility Criteria

Age1 Day - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients evaluated for Tranplantation at Hannover Medical School

You may qualify if:

  • Patients who receive upper and/or lower endoscopy during evaluation for transplantation

You may not qualify if:

  • patient already on waiting list

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

  • 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.

Study Officials

  • Jochen Wedemeyer, MD

    MHH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. T. Weismüller

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

February 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 10, 2011

Record last verified: 2011-10

Locations