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Comparing autofluorescence endoscopy and white light video endoscopy for surveillance of patients with familial colorectal cancer.


- candidate number5969
- NTR NumberNTR1865
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2009
- Secondary IDsMEC-2005-199 Medical ethical committee Erasmus MC University Medical Center
- Public TitleComparing autofluorescence endoscopy and white light video endoscopy for surveillance of patients with familial colorectal cancer.
- Scientific TitleComparing autofluorescence endoscopy and white light video endoscopy for surveillance of patients with familial colorectal cancer.
- ACRONYMCAESAR study
- hypothesisAutofluorescence 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) studiedColorectal cancer, Lynch syndrome
- Inclusion criteria1. 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 criteria1. 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 juvenile polyposis;
6. Patients unable or not willing to give informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 11-nov-2005
- planned closingdate14-mei-2009
- Target number of participants100
- InterventionsColonoscopic 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 outcomeThe difference between WLE and AFE for detection of adenomatous lesion or CRC during colonoscopy in patient with HNPCC or familial CRC.
- Secondary outcome1. Histological difference of the lesions detected only by WLE or only by AFE;
2. Duration of the procedure for WLE and AFE.
- TimepointsInterim analysis after inclusion of fifty participants.
- Trial web sitenone
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD D. Ramsoekh
- CONTACT for SCIENTIFIC QUERIESMD D. Ramsoekh
- Sponsor/Initiator Erasmus Medical Center, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryObjective:
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.
Design:
Prospective single centre study.
Setting:
Tertiary referral centre.
Population:
Asymptomatic patients originating from Lynch syndrome or familial colorectal cancer families.
Intervention:
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.
Outcome measure:
The difference in sensitivity between WLE and AFE for the detection of adenomas in patients with LS or familial CRC.
Analysis:
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)
- RECORD17-jun-2009 - 6-okt-2009


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