Comparison of the Diagnostic Accuracy Between Three Dimensional and Standard Colonoscopy of Colorectal Polyps

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

Colorectal cancer (CRC) is one of the most common cancers worldwide. These malignancies originate in the colon or rectum, and the majority evolve from pre-existing colonic adenomas (a type of colon polyp). Early detection, identification, and removal of these precancerous lesions can effectively reduce the morbidity and mortality of colorectal cancer.

However, not all colonic polyps possess a significant risk of malignant transformation. Polyps can generally be subdivided into "neoplastic" and "non-neoplastic" lesions; major non-neoplastic polyps include inflammatory polyps, hamartomas, lymphoid polyps, mucosal prolapse polyps, and hyperplastic polyps. On the other hand, neoplastic polyps have the potential to develop into malignancies, primarily including adenomatous polyps and serrated polyps. Adenomatous polyps account for more than 50% of all colonic polyps and are the most common precancerous lesions for CRC. Clinically, they can be further classified into tubular, tubulovillous, or villous adenomas based on histological subtypes. As for serrated polyps, traditional serrated adenomas (TSAs) and sessile serrated lesions (SSLs) possess carcinogenic potential.

During a colonoscopy, detecting colonic polyps is crucial, but it is equally important to identify which polyps have malignant potential. This allows for the accurate resection of true precancerous lesions while avoiding the procedural risks associated with unnecessary polypectomies. Furthermore, in rare instances, diminutive polyps may harbor cancer with deep submucosal invasion. Due to the risks of incomplete resection and lymph node metastasis, such lesions are not suitable for endoscopic resection. Therefore, achieving an accurate endoscopic diagnosis is a key step in determining the most appropriate management strategy for colonic polyps.

To improve the diagnostic accuracy of endoscopy for colonic polyps, multiple modalities have been developed, including careful observation of lesion morphology, as well as various image-enhanced technologies and chromoendoscopy. Meanwhile, three-dimensional (3D) endoscopy, a novel technology, offers superior spatial resolution and depth perception compared to conventional two-dimensional (2D) endoscopy. Studies have confirmed that 3D endoscopy can improve the adenoma detection rate (ADR) due to its enhanced ability to detect flat and inconspicuous lesions. However, whether 3D colonoscopy can also enhance the endoscopic diagnostic accuracy for colonic polyps remains to be explored. Therefore, we designed a randomized controlled trial (RCT) to investigate whether 3D colonoscopy can improve the diagnostic accuracy of colonic polyps compared to conventional 2D colonoscopy.

Eligibility criteria

Qualifiers

Patients aged 18 years or older.

Patients who meet the indications for undergoing colonoscopy.

Disqualifiers

Patients younger than 18 years of age or those with contraindications precluding them from undergoing a colonoscopy.

Patients with familial hereditary colorectal cancer or colonic polyposis syndromes.

Patients with inflammatory bowel disease (IBD).

Subjects who are unable to complete the colonoscopy or those with poor bowel preparation.

Trial design

Treatments tested in this trial

  • 3D MonoStereo

Treatment groups

600 Participants
are divided into 2 treatment groups

Locations

This trial has no locations