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Vacuum Assisted Excision of Duct papilloma in patients with nipple discharge due to papilloma and its feasibility with outcome

Vacuum Assisted Excision of Intraductal Papilloma- a feasibility study in Indian setting- Randomized control trial - VAEIP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087419
Enrollment
40
Registered
2025-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: D24- Benign neoplasm of breast

Interventions

Intervention1: Surgical Excision: Total duct excision or Microdochectomy will be done by standard techniques as indicated Control Intervention1: Vacuum-assisted excision (VAE): VAE will be performed w

Sponsors

AIIMS Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with core needle biopsy proven intraductal papilloma, and of size less than 1.5cm

Exclusion criteria

Exclusion criteria: Exclusion criteria for VAE: 1. Patients having frank concomitant malignancy. 2. Pregnancy and breast feeding. 3. Patients not giving consent for the procedure. Exclusion criteria for Surgical Excision: 1. Patients having frank concomitant malignancy. 2. Pregnancy and breast feeding. 3. Patients not giving consent for the procedure. 4. Patients with concomitant active infection. 5. Not fit for general or regional anesthesia 6. Previous history of intraductal papilloma/ duct excision same breast

Design outcomes

Primary

MeasureTime frame
To know if VAE is non-inferior to surgical excision in terms of complete papilloma removal and complication ratesTimepoint: 1. Pain at baseline, 1 month, 6 months, 12 months 2. Duration of procedure at baseline 3. Post operative complications a) hematoma- at baseline, 1 week, 1 month, 6 months b) surgical site infection at baseline, 1 week, 1 month, 6 months, 12 months c) skin necrosis at baseline, 1 week, 1 month, 6 months, 12 months 4. Residual disease at baseline, 1 month, 6 months, 12 months 5. Recurrent disease at 1 month, 6 months, 12 months 6. Need for future surgical excision at 1 month, 6 months, 12 months—

Secondary

MeasureTime frame
assessing patient-reported outcomes, cost-effectiveness, and cosmetic satisfaction.Timepoint: Clinical follow up at one, six and twelve months will be done by a blinded outcome assessor from the department of Surgical Disciplines.—

Countries

India

Contacts

Public ContactANKITA AGGARWAL

All India Institute of Medical Sciences, Delhi

dr.ankitaaggarwal@gmail.com9968856454

Outcome results

None listed

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