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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012410

Enrollment

Registered

2017-05-10

Start date

2018-02-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C44.5 D01.3 C21

Interventions

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 stud

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: HIV positivity Men sex with men (MSM) Forseen for routine AIN screening

Exclusion criteria

Exclusion criteria: Iodine allergy Vinegar allergy Thyroid function No informed consent Condition after anal surgery

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Switzerland

Contacts

Public ContactStephan Baumeler

Kantonsspital St. GallenKlinik für Gastroenterologie/Hepatologie

stephan.baumeler@kssg.ch+41 71 494 64 95

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026