|- candidate number||5969|
|- NTR Number||NTR1865|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jun-2009|
|- Secondary IDs||MEC-2005-199 Medical ethical committee Erasmus MC University Medical Center|
|- Public Title||Comparing autofluorescence endoscopy and white light video endoscopy for surveillance of patients with familial colorectal cancer.|
|- Scientific Title||Comparing autofluorescence endoscopy and white light video endoscopy for surveillance of patients with familial colorectal cancer.|
|- ACRONYM||CAESAR study|
|- hypothesis||Autofluorescence endoscopy (AFE) has a higher sensitivity for the detection of colorectal adenomas in comparison with white light video endoscopy (WLE).|
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Lynch syndrome|
|- Inclusion criteria||1. Age 18 years or older;|
2. Patients with Lynch syndrome, defined
according to the Amsterdam 2 criteria;
3. Patients with familial colorectal cancer
(IKR Guidelines; www.oncoline.nl):
A. One first degree family member with
colorectal carcinoma diagnosed at a
relative young age or in two second
degree family members and;
B. Lynch syndrome or Familial
adenomatous polyposis is excluded.
|- Exclusion criteria||1. Under 18 years of age;|
2. Patients with (attenuated) FAP;
3. Coagulopathy (prothrombin time < 50%
of control; partial thromboplastin time >
50 seconds) or anticoagulantia that can
not be discontinued;
4. Patients with inflammatory bowel disease;
5. Patients with Peutz-Jeghers syndrome or
6. Patients unable or not willing to give
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||11-nov-2005|
|- planned closingdate||14-mei-2009|
|- Target number of participants||100|
|- Interventions||Colonoscopic surveillance with both WLE and AFE in high risk patients (Lynch syndrome or familial colorectal cancer). In case of the detection of colorectal lesions (adenoma, colorectal cancer or hyperplasia) these lesions were removed by polypectomy. AFE was compared to WLE (active control) with respect to the diagnostic yield (detection of colorectal lesions).|
|- Primary outcome||The difference between WLE and AFE for detection of adenomatous lesion or CRC during colonoscopy in patient with HNPCC or familial CRC.|
|- Secondary outcome||1. Histological difference of the lesions
detected only by WLE or only by AFE;|
2. Duration of the procedure for WLE and
|- Timepoints||Interim analysis after inclusion of fifty participants.|
|- Trial web site||none|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD D. Ramsoekh|
|- CONTACT for SCIENTIFIC QUERIES||MD D. Ramsoekh|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Gastroenterology and Hepatology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Rotterdam|
|- Brief summary||Objective: |
To compare the sensitivity of autofluorescence endoscopy (AFE) and white light video endoscopy (WLE) for the detection of colorectal adenomas in high-risk patients belonging to Lynch syndrome (LS) or familial colorectal cancer (CRC) families.
Prospective single centre study.
Tertiary referral centre.
Asymptomatic patients originating from Lynch syndrome or familial colorectal cancer families.
Patients were examined with either WLE followed by AFE or AFE followed by WLE. Back-to-back colonoscopy was performed by two blinded endoscopists. All lesions were removed during the second endoscopic procedure. Lesions missed during the second procedure were identified and removed on 3rd pass. The sensitivity calculations for colorectal adenomas were based on histology results.
The difference in sensitivity between WLE and AFE for the detection of adenomas in patients with LS or familial CRC.
McNemar’s test, the Mann-Whitney U test, the Fisher exact test, the t-test and multivariable proportional odds logistic regression analysis.
|- Main changes (audit trail)|
|- RECORD||17-jun-2009 - 6-okt-2009|