Clinical trial NCT03903497: WASP Classification in Diagnosis of Diminutive Colorectal Polyps
Official title: Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diminutive Colorectal Polyps
Keywords: Narrow band imaging
WASP classification
Diminutive colorectal polyps
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: Jilin People's Hospital
name: Wafangdian Third Hospital
name: Dezhou People's Hospital
name: Liaocheng People's Hospital
name: Wenzhou Central Hospital
name: Yichun People's Hospital
name: The Third Xiangya Hospital of Central South University
name: Shenzhen Baoan People's Hospital
name: Xinxiang Central Hospital
name: Wuwei Cancer Hospital
name: Zunyi Medical College
name: Yaan People's Hospital
First posted: 2019-04-04
Enrollment: 2640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Colonoscopy with NBI using the WASP classification
Primary purpose: DIAGNOSTIC

Brief summary: Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.

In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients aged more than 18 years old
* Patients with at least one diminutive colorectal polyp

Exclusion Criteria:

* Patients with poor bowel preparation
* Paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
* Patients with advanced colorectal cancer
* Patients with missed histology information of resected polyps or missed resected specimen
* Patients with emergency operation during colonoscopy
* Patients with unfinished colonoscopy due to any reason

Primary outcomes:
measure: Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis
timeFrame: Within two weeks after polypectomy
measure: Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
timeFrame: Within two weeks after polypectomy
measure: Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis
timeFrame: Within two weeks after polypectomy
Secondary outcomes:
measure: Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps
timeFrame: Within two weeks after polypectomy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: