No registrations found.
ID
Source
Brief title
Health condition
Lynch syndrome, familial colorectal cancer
colonoscopic surveillance
Dutch:
Lynch syndroom
familiaire colorectaal carcinoom
colonoscopische surveillance
Sponsors and support
Intervention
Outcome measures
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
AFE.
Background 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.
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.
Study objective
Autofluorescence endoscopy (AFE) has a higher sensitivity for the detection of colorectal adenomas in comparison with white light video endoscopy (WLE).
Study design
Interim analysis after inclusion of fifty participants.
Intervention
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).
Erasmus MC University Medical Center
's 's Gravendijkwal 230
D. Ramsoekh
Dept. of Gastroenterology and Hepatology
Erasmus MC University Medical Center
's 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 70 34681
d.ramsoekh@erasmsumc.nl
Erasmus MC University Medical Center
's 's Gravendijkwal 230
D. Ramsoekh
Dept. of Gastroenterology and Hepatology
Erasmus MC University Medical Center
's 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 70 34681
d.ramsoekh@erasmsumc.nl
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
juvenile polyposis;
6. Patients unable or not willing to give
informed consent.
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 |
|---|---|
| NTR-new | NL1756 |
| NTR-old | NTR1865 |
| Other | Medical ethical committee Erasmus MC University Medical Center : MEC-2005-199 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |