The main objective is to compare the accuracy of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to assess: Reproducibility, precision of the measurements, time needed for measurement and…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is establishing Cohens* Kappa coefficient in
determining the size of polyps for the following categories: <5mm, 5-9mm,
>=10mm, for the interobserver agreement between AccuMeasure and biopsy forceps
assisted measurement.
Secondary outcome
Secondary objectives are to assess:
• Reproducibility of AM using successive measurements of the same polyp;
• Precision estimate of AM as compared to optical- and biopsy forceps assisted
assessment;
• Size differences for optical-, biopsy forceps-, and AM assessment as compared
to pathology size measurement;
• Subgroups based on polyp morphology (i.e., sessile or adenomatous lesions);
• Time needed to measure polyp size and learning curve;
• Endoscopist advised surveillance interval based on optical assessment during
colonoscopy, on measurement with an open biopsy forceps, and on measurement
with AccuMeasure.
• Safety, in terms of (severe) adverse events up to 30 days post-procedure
Background summary
Recent updates of the guidelines on polyp surveillance of the American Society
of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal
Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator
of malignant transformation to colorectal cancer (CRC). However, the
interobserver variability in polyp size assessment between optical diagnosis of
endoscopists and pathologists is considerable. This may lead to incorrect
surveillance intervals in patients at risk for developing colorectal cancer,
which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to
assess the accuracy of a new laser-based measurement system (AccuMeasure, VTM
Technologies Ltd.) for polyps during colonoscopy.
Study objective
The main objective is to compare the accuracy of polyp size measurement by
AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to
assess: Reproducibility, precision of the measurements, time needed for
measurement and learning curve, endoscopists advised surveillance intervals
based on both measurement methods, and safety.
Study design
Multicenter, randomized, parallel group, endoscopist blinded study, including
the measurement of 138 polyps during standard colonoscopy. With a polyp
detection rate of approximately 40%1, this results in up to 345
patients/colonoscopies to be included. Enrollment will conclude once 138 polyps
are included in the study.
Intervention
Optical assessment will be performed upon identification of the polyp. Then,
measurement with AccuMeasure and biopsy forceps will be performed in a
randomized order. The endoscopist will remain blinded to the AccuMeasure
measurement outcomes, to avoid a learning effect that could influence
subsequent measurements. Additionally, two off-line assessments with the
AccuMeasure will be performed after colonoscopy by a member of the research
team to assess reproducibility.
Study burden and risks
There will be no direct benefit for patients participating in this study.
Nonetheless, the burden of participating for subjects is limited to the extra
time (minutes) during colonoscopy needed for additional polyp size measurement.
The added risks associated with participating in this study are considered
negligible. In the future, patients could benefit from a more accurate size
assessment, as this possibly results in more timely and efficient colonoscopy
surveillance intervals that are better suited to the risk of malignant
transformation.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
• Adult patients (>18 years)
• Scheduled for screening, surveillance, or diagnostic colonoscopy
• Polyps of all forms <= 25mm as assessed by the endoscopist
Exclusion criteria
• Therapeutic colonoscopy
• Inflammatory bowel disease (IBD)
• American Society of Anesthesiologists score of >3
• Inadequate bowel preparation (Boston bowel preparation scale score [BBPS] <2
per segment);
• No polyps identified during colonoscopy or only small (<5mm) hyperplastic
rectal polyps
• Inadequately corrected anticoagulation disorder or anticoagulation medication
use
• Inability to provide informed consent
Design
Recruitment
Medical products/devices used
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 | NL80961.091.22 |