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Completed

NCT Number: NCT06603948

Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection

Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. This technology, combined in the latest generation SonoScape's endoscopes (SonoScape Co, Shenzhen, China) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with SFI are encouraging but are scanty and limited to back-to back studies.

This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI is superior to WLI endoscopy in terms of adenoma detection

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Key information

Conditions

Colorectal Adenoma

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital, Beijing, Beijing Municipality, China

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About this study

45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of colonoscopy. All procedures are performed with a high-definition HD-580 series videocolonscopes with or without magnification (SonoScape Co, Shenzhen, China).

The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Male or female aged 45 to 85
  • 2. Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
  • 3. Capable of providing informed consent and agreeing to participate
  • 4. Able and willing to follow all research processes

Exclusion criteria

  • 1. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
  • 2. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
  • 3. Pregnant or lactating patients;
  • 4. Known to have polyposis syndrome;
  • 5. Patients with gastrointestinal bleeding;
  • 6. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
  • 7. Patients with contraindications to tissue biopsy;
  • 8. History of allergies to the ingredients in intestinal cleansers;
  • 9. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
  • 10. Researchers believe that patients are not suitable to participate in the trial;
  • 11. Have had drug or alcohol abuse or psychological disorders in the past five years.

Treatment and study plan

Spectral Focused Imaging

Device

Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy

White light imaging

Device

Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy

Primary outcomes

  1. Adenoma detection rate (ADR)

    Time frame: 14 days

    ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy

Secondary outcomes

  1. Polyp Detection Rate(PDR)

    Time frame: 14 days

    Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.

  2. Sessile serrated lesion detection rate (SSLDR)

    Time frame: 14 days

    SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy

  3. Advanced Adenoma Detection Rate

    Time frame: 14 days

    Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy.

  4. Mean number of polyps per patient

    Time frame: 14 days

    Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy.

  5. Mean number of Adenomas per patient(MAP)

    Time frame: 14 days

    Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy.

  6. Detection Rate of Polyps of Different Sizes

    Time frame: 14 days

    It is calculated by dividing the number of patients with large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) polyps by the total number of patients undergoing colonoscopy.

  7. Detection Rate of Adenomas with Different Morphologies

    Time frame: 14 days

    It is calculated by dividing the number of patients with 0-Ip, 0-Is, 0-Isp, and 0-IIa adenomas by the total number of patients undergoing colonoscopy.

  8. Average Number of Adenomas with Different Morphologies

    Time frame: 14 days

    It is calculated by dividing the number of 0-Ip, 0-Is, 0-Isp, and 0-IIa adenomas by the total number of patients undergoing colonoscopy.

  9. Average Number of Polyps of Different Sizes

    Time frame: 14 days

    It is calculated by dividing the number of large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) polyps by the total number of patients undergoing colonoscopy.

  10. Detection Rate of Adenomas of Different Sizes

    Time frame: 14 days

    It is calculated by dividing the number of patients with large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) adenomas by the total number of patients undergoing colonoscopy.

  11. Average Number of Adenomas of Different Sizes

    Time frame: 14 days

    It is calculated by dividing the number of large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) adenomas by the total number of patients undergoing colonoscopy.

  12. Detection Rate of Adenomas in Different Locations

    Time frame: 14 days

    It is calculated by dividing the number of patients with detected adenomas in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.

  13. Average Number of Adenomas in Different Locations

    Time frame: 14 days

    It is calculated by dividing the number of detected adenomas in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.

  14. Detection Rate of Polyps in Different Locations

    Time frame: 14 days

    It is calculated by dividing the number of patients with detected polyps in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.

  15. Average Number of Polyps in Different Locations

    Time frame: 14 days

    It is calculated by dividing the number of detected polyps in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.

  16. Detection Rate of Polyps with Different Morphologies

    Time frame: 14 days

    It is calculated by dividing the number of patients with 0-Ip, 0-Is, 0-Isp, and 0-IIa polyps by the total number of patients undergoing colonoscopy.

  17. Average Number of Polyps with Different Morphologies

    Time frame: 14 days

    It is calculated by dividing the number of 0-Ip, 0-Is, 0-Isp, and 0-IIa polyps by the total number of patients undergoing colonoscopy.

  18. Insertion Time of Colonoscopy

    Time frame: 14 days

    The time taken from the rectum to the cecum.

  19. Withdrawal Time of Colonoscopy

    Time frame: 14 days

    The time taken to complete the examination starting from the cecum.

  20. Cecal Intubation Rate

    Time frame: 14 days

    It is calculated by dividing the number of colonoscopies that reach the cecum by the total number of colonoscopies performed.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • First Affiliated Hospital of Ningbo University
  • First Affiliated Hospital of Xinjiang Medical University
  • Nanchong Central Hospital
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • Seventh Medical Center of PLA Army General Hospital
  • Tongji Hospital
  • West China Fourth Hospital

Registry information

Official study title

Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging: a Parallel Randomized Controlled Trial

Acronym: SFI verus WLI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 2, 2025

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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