Evaluation of High Resolution Endoscopy Compared to the High Resolution Anoscopy for Detection of Early Dysplastic or Neoplastic Lesions of the Anal Canal in High-Risk Patients: an Open Randomised Crossover Study

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00012410
• Date of registration: 10/05/2017
• Prospective Registration: Yes
• Primary sponsor: Kantonsspital St. GallenKlinik für Gastroenterologie/Hepatologie
• Public title: Evaluation of High Resolution Endoscopy Compared to the High Resolution Anoscopy for Detection of Early Dysplastic or Neoplastic Lesions of the Anal Canal in High-Risk Patients: an Open Randomised Crossover Study
• Scientific title: Evaluation of High Resolution Endoscopy Compared to the High Resolution Anoscopy for Detection of Early Dysplastic or Neoplastic Lesions of the Anal Canal in High-Risk Patients: an Open Randomised Crossover Study - AIN Study
• Date of first enrolment: 26/02/2018
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00012410
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: crossover; Study design purpose: diagnostic
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Stephan Baumeler
• Affiliation: Kantonsspital St. GallenKlinik für Gastroenterologie/Hepatologie

• Name: Stephan Baumeler
• Affiliation: Kantonsspital St. GallenKlinik für Gastroenterologie/Hepatologie

Key inclusion & exclusion criteria

Inclusion criteria: HIV positivity
Men sex with men (MSM)
Forseen for routine AIN screening
Exclusion criteria: Iodine allergy
Vinegar allergy
Thyroid function
No informed consent
Condition after anal surgery

Age minimum: 18 Years
Age maximum: None
Gender: Male

Health Condition(s) or Problem(s) studied

Skin of trunk

C44.5
D01.3
C21

C44.5

Malignant neoplasm of anus and anal canal

Anus and anal canal

D01.3

Intervention(s)

Group 1: The patients are recruited by the Department of Infectiology. The informed consent is obtained by an infectologist who is familiar with the protocol and study specific examinations.

The study-specific examinations and interviews are all carried out during a consultation, lasting about 45 minutes. Before study specific examinations questions about epidemiology are raised.

The sequence of examinations (first anoscopy / HRA or endoscopy/HRE) is randomized. Randomization is performed by the SecuTrial program.

The subsequent regular AIN screening examination includes, as a standard, a perianal and endoanal inspection using colposcopic high-resolution anoscopy (HRA). The examination is performed very similar to the gynecological screening test for dysplasia/neoplasia of the cervix with a colposcope, an optical microscope. The latest guidelines are being implemented.

In addition to the Standard Screening examination, a high-resolution endoscopy (HRE) is performed in the study patients. This examination is carried out analogously to a routinely performed flexible rectosigmoidoscopy .

After examination of the situs without staining with both modalities (HRA and HRE), standard coloring techniques of the anal canal are performed according to current guidelines. First staining with acetic acid 5% and then staining with lugol solution 2% (iodine solution). Each followed by a new assessment with both modalities HRA and HRE.

For both HRA and HRE photodocumentation and a schematic recording of the findings as well as a morphological description according to the current guidelines are carried out. All suspicious lesions are biopsied - similar to the AIN screening of patients outside the study.

Randomization determines whether the examination starts with anoscopy (HRA) o

Primary Outcome(s)

All data are collected during a single consultation. AIN = anal intraepithelial neoplasia
HRA= high Resolution Anoscopy (Coloposcope)
HRE= high Resolution Endoscopy

The primary endpoint examines if there is a difference in the positive predictive value (PPV) for histological confirmed AIN diagnosed with HRA resp. HRE under no stain, aceto acid staining and lugol staining. All examinations are obtained during one 45 Minute appointment.

PPV=(number of patients with true positive Finding)/(number of patients with true positive findings+number of patients with flase positive findings)

The following hypothesis will be examined:
H0: PPV HRA = PPV HRE
H1: PPV HRA ? PPV HRE

The null hypothesis (H0) of the primary endpoint assumes no difference between the PPV for HRA and the PPV for HRE. The alternative hypothesis (H1) assumes that the two PPV are not the same.

Secondary Outcome(s)

All data are collected during a single consultation.

1. The secondary endpoint examines if there is a difference in the AIN detection rate (ADR) for histological confirmed AIN diagnosed with HRA resp. HRE under no stain, aceto acid staining and lugol staining seperately.


ADR=(at least one histological confirmed AIN diagnosed by HRA resp.HRE)/(Total number of Patients examinated by HRA resp.HRE)

2. PPV for HRA and HRE separated for no stain and staining with aceto acid (AA) and lugol iodine. The hypothesis for a difference between HRA and HRE as well as between the no stain and the two staining methods will be examined.

3. Rate of AIN found per AIN positive Patient

4. Per-patient AIN miss rate.

5. Describe locations where AIN were found with HRA resp. HRE separated for no staining, AA and lugol

Source(s) of Monetary Support

Medizinisches ForschungszentrumForschungskommission

Olympus Europe

Ethics review

Status: Approved
Approval date: 01/05/2017
Contact:

Ethikkommission Ostschweiz (EKOS) [Ethikkommission der Ostschweiz]

[phone]

Results

• URL: http://drks.de/search/en/trial/DRKS00012410#studyResults