advanced adenomen Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Netherlands
Outcome results
None listed