The primary objective of this study is to evaluate the prevalence and risk of advanced colorectal neoplasia in asymptomatic non-PSC post-liver transplant recipients compared to an age- and sex matched general population.Secondary Objectives- To…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is defined as the prevalence and risk of advanced colorectal
neoplasia detected by a post-LT colonoscopy program compared to the
asymptomatic general population.
Secondary outcome
- For patients with pre-transplant colonoscopy protocol, the prevalence of
advanced colorectal neoplasia at surveillance colonoscopy will be determined
and compared to the general population where a surveillance procedure has been
performed. As comparison, the results from the project *Surveillance after
polypectomy*- Towards efficient guidelines* from the Department of Public
Health of the Erasmus MC University Medical Centre will be used. This study is
now in process in the Erasmus MC in 2006 (File number 80-00702-98-088).
Furthermore, studies from the literature will be used that evaluate yield of
surveillance colonoscopy stratified for baseline colonoscopy findings.
- For patients without pre-transplant colonoscopy work-up, the prevalence of
advanced colorectal neoplasia will be determined and compared to non-LT cohorts
for advanced neoplasia in asymptomatic individuals reported in the literature.
- Difference in prevalence and risk (Risk Difference [RD]) of advanced
neoplasia between post-LT patients with pre-LT colonoscopy and patients without
pre-LT colonoscopy.
- To evaluate the differences between locations of neoplasia, morphology of
neoplasia and age of post-LT patients compared to non-LTx cohorts reported in
the literature.
Background summary
Liver transplantation (LT) is being performed in an increasing number of
patients nowadays. It is the most effective treatment for multiple end stage
liver diseases with excellent results in short and midterm outcomes. However,
concerning long term outcome several malignancies have been observed. Whether
there is an increased risk for colorectal cancer in LT recipients is
controversial. Some studies have shown an increased risk for CRC and
colonoscopy surveillance has been advised. However, others could not confirm
this increased risk. A markedly increased risk for CRC is established in
primary sclerosing cholangitis (PSC) patients, both in patients with and
without LT. For PSC patients, surveillance guidelines for colorectal neoplasia
are recommended in terms of annual surveillance colonoscopy. However, the need
for adjustment in surveillance guidelines concerning CRC in the non-PSC
post-liver transplantation setting is not yet clear. Additionally, the value of
pre-transplant colonoscopy screening is still not clarified due to
underreporting of the pre-transplant screening work-up in published studies.
This may result in differences in yield of colonic adenomas in the
post-transplant setting.
Study objective
The primary objective of this study is to evaluate the prevalence and risk of
advanced colorectal neoplasia in asymptomatic non-PSC post-liver transplant
recipients compared to an age- and sex matched general population.
Secondary Objectives
- To evaluate the observed prevalence and risk of advanced neoplasia found by a
colonoscopy in asymptomatic non-PSC post liver transplant recipients with
pre-transplant colonoscopy screening compared to the age and sex matched
general population.
- To evaluate the observed prevalence and risk of advanced neoplasia found by a
colonoscopy in asymptomatic non-PSC post liver transplant recipients without
pre-transplant colonoscopy protocol compared to the age- and sex matched
general population.
- To evaluate the difference in prevalence and risk of advanced colorectal
neoplasia 5 years post-LT in asymptomatic non-PSC post-liver transplant
recipients with pre-transplant colonoscopy compared to asymptomatic non-PSC
post-liver transplant recipients without pre-transplant screening colonoscopy.
Study design
Prospective observational intervention study in a multi-center setting
Study burden and risks
A colonoscopy will be performed and include bowel preparation, burden of the
colonoscopy in terms of discomfort and complication risks (0.3%), but possible
risk reduction for CRC. Most common complications that may occur in colonoscopy
procedures are perforation and bleeding as well as cardiopulmonary events such
as depressions.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Group A: Post liver transplant patients without pre-LT colonoscopy
Patients who
- Have a follow-up of at least 5 years after receiving their first LT.
- Have had orthotopic liver transplantation (OLT).
- Have had non-PSC transplant indications;Group B
• B1 Post liver transplant patients with pre-LT colonoscopy negative findings:
Patients who
- Have a follow-up of at least 5 years after receiving their first LTx
- Have had orthotopic liver transplantation (OLT)
- Are Non-PSC transplant indications
Colonoscopy results within 5 years of post-LT follow-up in post-LTx patients will also be included in the analyses
Patients with a post-LTx colonoscopy before 5 years of post-LTx follow-up who are still alive at time at inception, will also be asked to participate in the post liver transplant colonoscopy program (>= 5 year FU)
B2 Post liver transplant patients with pre-LTx colonoscopy positive findings:
Patients who
- Have a follow-up of at least 5 years post-LT
- Have had orthotopic liver transplantation (OLT)
- Have had non-PSC transplant indications
If patients have 3 or more adenomas at pre-LT colonoscopy (which require intensified surveillance work-up in the Dutch polypectomy guideline10), the follow-up colonoscopy results within 3 years of follow-up after the index colonoscopy in post-LTx patients will be included in the analyses. If patients did not receive their appropriate 3-year surveillance colonoscopy, they will be asked for inclusion.
Exclusion criteria
Patients who:
- have had an other bowel screening procedure pre-LT such as barium enema and/or sigmoidoscopy)
- are unable or not willing to give informed consent
- do have coagulopathy (prothrombin time < 50% of control; partial thromboplastin time > 50 seconds) or patients who have anticoagulants (marcoumar or sintrom) that can not be stopped
- are under 18 years of age
- have had auxiliary LTx
- have PSC
- are known with IBD ( UC or Crohn*s disease)
- have undergone a total colectomy
- do not have a post-LTx follow-up colonoscopy and are dead at time of inception
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32961.078.10 |