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Completed

NCT Number: NCT03712059

National Colorectal Polyp Care

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

About this study

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.

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

FIT test and colonoscopy

Diagnostic Test

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.

Polypectomy and biopsy

Diagnostic Test

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.

Classification

Diagnostic Test

Pathology of polyps is classified by endoscopists through NICE principle and the performance of classification between endoscopists and computer is compared.

Primary outcomes

  1. 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

Secondary outcomes

  1. Complete resection rate of polypectomy

    Time frame: 24 hours

  2. Specificity and sensitivity of endoscopists and artificial intelligence-assisted system in classifying polyps

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • 175 medical centers in China

Registry information

Official study title

National Colorectal Polyp Care for Diagnosis, Classification and Resection

Acronym: NCPC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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