Clinical trial NCT02929641: Evalution of Optical Enhancement With Magnification for Polyop Histology
Official title: Evaluation of a New Image-enhanced Endoscopic Technology With Magnification Using I-scan Optical Enhancement for Prediction Colorectal Polyp Histology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Polyps
Keywords: Optical Enhancement technology
coloractal polyp prediction
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who experence an examation of coloscopy found polyps.

Brief summary: When a polyp is found, it woulf be recorded by a white-light and OE1 model with magnification for assessing and predicting its histology. After that, its really histology will be reported by an pathologist.

When a polyp is found, OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. The video of all procedure was recorded.

Detailed description: After bowel cleansing with 2L polyethylene glycol, patients received colonoscopy under propofol intravenous anesthesia. When a polyp was found, we began to wash it and record the video. OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. Biopsy of the polyps were taken after observation, and the size of polyps was estimated by the biopsy forceps. The information of patient age, gender polyp morphology and location were recorded. After a video transcoding and clipping, the pathology type of each video clip was predicted by an endoscopist. The sensitivity, specificity, positive predicting value (PPV), negative predicting value (NPV) and accuracy were calculated. The pathology types of polyps were classified by non-neoplastic polyps and neoplastic polyps according to Vienna Classification. Statistics were performed by NCSS 11 and R software (Version 3.3.2).

Eligibility criteria: Inclusion Criteria:

* Patients will be included if they are found polyps during endoscopy procesure.

Exclusion Criteria:

* Inflammatory bowel disease
* Biopsies were not available.
* Unable to provide informed consent.

Primary outcomes:
measure: To evaluated the accuracy of i-scan OE system with magnification endoscopy on real-time predicting the pathology types of colorectal polyps.
timeFrame: 18 months
Secondary outcomes:
measure: To evaluate whether the diagnostic value of OE with magnification can meet the thresholds of "resect-and-discard" and "diagnose-and-leave" strategies outlined by Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) document.
timeFrame: 18 months
measure: To assess the diagnostic value and inter-observer agreement of OE on post-hoc differentiating pathology of colorectal polyps.
timeFrame: 18 months
measure: To assess the value of magnification optical enhancement on classification of colorectal polyps using a deep learning model
timeFrame: 18 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Basford PJ, Longcroft-Wheaton G, Higgins B, Bhandari P. High-definition endoscopy with i-Scan for evaluation of small colon polyps: the HiSCOPE study. Gastrointest Endosc. 2014 Jan;79(1):111-8. doi: 10.1016/j.gie.2013.06.013. Epub 2013 Jul 17.
citation: Neumann H, Fujishiro M, Wilcox CM, Monkemuller K. Present and future perspectives of virtual chromoendoscopy with i-scan and optical enhancement technology. Dig Endosc. 2014 Jan;26 Suppl 1:43-51. doi: 10.1111/den.12190. Epub 2013 Oct 23.