NCT05060640

ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Fernando Pessoa · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

Detailed description

Procedures in all patients: 1. Digital anorectal evaluation 2. Colonoscopy with retroflection and visualization of the anal squamocolumnar junction 3. After identification of this area 5% acetic acid will be applied. 4. Visualization under NBI/BLI. 5. Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).

Conditions

• AIN3
• AIN2
• HSIL, High Grade Squamous Intraepithelial Lesions

Interventions

Type	Name	Description
PROCEDURE	Detection of anal HSIL in a routine colonoscopy.	Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI.

Timeline

• Start date: 2021-08-26
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-09-29
• Last updated: 2022-12-12

Locations

1 site across 1 country: Portugal