National Colorectal Polyp Care (NCPC)

December 14, 2021 updated by: Zhaoshen Li, Changhai Hospital

National Colorectal Polyp Care for Diagnosis, Classification and Resection

This study has three main purposes：screening: the first purpose is to evaluate the diagnostic value of combintion of the life risk factors and immunochemical fecal occult blood test (FIT) on detection of colorectal neoplasia in Chinese population; resection: the second objective is to investigate the complete resection rate of colorectal adenoma and risk factors of incomplete resection in China; identification and classification: the third objective is to initially establish an artificial intelegence-assissted recognition and classification system of polyp based on deep learning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center cross-sectional survey and diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Naval Medical University), which is conducted at about 175 digestive endoscopy centers nationwide in China, with the expectation of including 12,000 patients (10,000 screenig and 2,000 adenoma resection). The basic characteristics of patients, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. According to the research purpose, the whole project can be divided into three sections.

  1. Screening section: All patients receive FIT test and colonoscopy, whose age, sex, family history, smoking history, body mass index (BMI), diabetes and other risk factors are collected by researchers through pad, equipped with a specially designed database and app. Using colonoscopy results as the gold standard, the risk prediction model for the Chinese population is explored, and the optimal strategy of colonoscopy practice for the Chinese established initially.
  2. Resection section: During the polypectomy, for all pathologically confirmed or NBI-predicted adenomas with size<10mm, 1-2 biopsies were randomly performed on the edge after resection to determine the completion rate of the polypectomy.
  3. Identification and classification section: For Patients regardless of cancer diagnosis or polypectomy, if there is polyp, observation of narrow band imaging (NBI) with or without magnification is required, with 4 white light and NBI images collected and reserved, respectively. If there is magnifying endoscopy, another 4 endoscopic images of magnification are also required. Endoscopists are invited to predict the pathology of polyps according to the NBI International Colorectal Endoscopic (NICE) classification principle and endoscopic images, and upload the pathological results and endoscopic images within 2-4 week after colonoscopy.

Study Type

Observational

Enrollment (Actual)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who referred to the outpatient and received colonoscopy.

Description

Inclusion Criteria:

  1. Age between 18 to 75 years old and patients with or without alarming gastrointestinal symptoms were analyzed separately.
  2. 3-4 L polyethylene glycol and foaming agent are used for bowel preparation.
  3. Withdrawal time ≥6mins (excluding the time of biopsy)

Exclusion Criteria:

  1. A history of acute myocardial infarction (within 6 months), severe heart, liver, kidney dysfunction, or mental illness.
  2. Patients taking anticoagulants such as aspirin and warfarin, or who have coagulopathy.
  3. Patients with inflammatory bowel disease and colon polyposis.
  4. History of colonic procedure (including surgery, polypectomy, EMR, and ESD) in the screening section
  5. Diameter of polyp greater than 1cm, lateral developmental lesions (LST), colon cancer, lesions requiring ESD and surgery
  6. Patients participating in other clinical trials now or within 60 days.
  7. Intestinal obstruction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening group
All patients receive FIT test and colonoscopy, whose age, sex, family history, smoking history, body mass index (BMI), diabetes and other risk factors are collected by researchers through pad, equipped with a specially designed database and app. Using colonoscopy results as the gold standard, the diagnostic value of risk prediction model for the Chinese population is explored, and the optimal strategy of colonoscopy practice for the Chinese established initially.
Diagnostic test: FIT test and colonoscopy
All included patients received FIT test and then colonoscopy, with the risk factors of CRC recorded. The diagnostic performance of predicting model (based on FIT and risk factors) and colonoscopy were compared.
Adenoma resection group
During the polypectomy of 2000 patients, for all pathologically confirmed or NBI-predicted adenomas with size<10mm, 1-2 biopsies were randomly performed on the edge after resection to determine the completion rate of the polypectomy.
Diagnostic test: Polypectomy and biopsy
All included patients received polypectomy, and then biopsy is performed on the edge of resection for patients with < 10 mm adenoma (confirmed by pathology or predicted by NBI images), with the complete resection rate of polyps being calculated.
Identification and classification group
For 12000 patients regardless of cancer diagnosis or polypectomy, if there is polyp, NBI (magnification) observation is required, with 4 white light and NBI images collected and reserved, respectively. If there is magnifying endoscopy, another 4 endoscopic images of magnification are also required. Endoscopists are invited to predict the pathology of polyps according to the NICE classification principle and endoscopic images, and upload the pathological results and endoscopic images within 2-4 week after colonoscopy.
Diagnostic test: FIT test and colonoscopy
All included patients received FIT test and then colonoscopy, with the risk factors of CRC recorded. The diagnostic performance of predicting model (based on FIT and risk factors) and colonoscopy were compared.
Diagnostic test: Polypectomy and biopsy
All included patients received polypectomy, and then biopsy is performed on the edge of resection for patients with < 10 mm adenoma (confirmed by pathology or predicted by NBI images), with the complete resection rate of polyps being calculated.
Diagnostic test: Classification
Pathology of polyps is classified by endoscopists through NICE principle and the performance of classification between endoscopists and computer is compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of colorectal neoplasia
Time Frame: 24 hours
Colorectal neoplasia included CRCs, adenomas, sessile serrated adenomas/polyps, traditional serrated adenomas/polyps, and hyperplastic polyps ≥10 mm, which were recommended to have a shorter surveillance interval after polypectomy
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete resection rate of polypectomy
Time Frame: 24 hours
24 hours
Specificity and sensitivity of endoscopists and artificial intelligence-assisted system in classifying polyps
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

175 medical centers in China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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