| CTRI Number |
CTRI/2021/05/033613 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
12/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
management of blood related nipple discharge by removal of milk ducts |
|
Scientific Title of Study
|
Comparison Of Patient Reported Outcomes In Patients With Blood Related nipple discharge undergoing mammary Duct Excision With 2.5 Cm Versus 5 Cm Length : A Randomised Controlled Exploratory Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Dhar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
CMET Department of Surgical Disciplines, AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dranitadharbhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dhar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
CMET Department of Surgical Disciplines, AIIMS
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dranitadharbhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneha Kumari |
| Designation |
MCh trainee |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
CMET Department of Surgical Disciplines, AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sunehajune@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Surgical Disciplines |
| Address |
All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anita Dhar |
AIIMS New Delhi |
Dept. of Surgical Disciplines, AIIMS New Delhi
South
DELHI |
9810198239
dranitadharbhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: D367||Benign neoplasm of other specifiedsites, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MAMMARY DUCT EXCISION - 2.5 cm |
In patients presenting with serosanguinous nipple discharge, evaluation will be done using USG/mammogram to rule out malignancy. After which mammary ducts will be removed with a length of 2.5 cm. |
| Comparator Agent |
Mammary duct excision - 5 cm |
In patients presenting with serosanguinous nipple discharge, evaluation will be done using USG/mammogram to rule out malignancy. After which mammary ducts will be removed with a length of 5 cm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
a) Ladies presenting with blood-related nipple discharge
b) No family history/ past history of carcinoma breast/ Ductal carcinoma in-situ
|
|
| ExclusionCriteria |
| Details |
a) clinically/ sonographically detected discrete breast lump
b) patient not willing for surgery
c) pregnant ladies/ lactating ladies
d) pre-surgery biopsy suggestive of atypia/ DCIS
e) past history of carcinoma breast
f) patients harboring mutations predisposing to breast cancer
g) family history of breast cancer
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare complication rate (nipple necrosis, nipple anaesthesia, retraction, scarring) in patients undergoing duct excision (Major duct excision/ microdochectomy) with 5 cm margin versus 2.5 cm margin in patients with blood related nipple discharge |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the cosmetic outcomes in both arms.
2. To assess patient satisfaction rate in terms of pre and post-operative pain and resolution of symptoms in both arms.
3. Comparison of recurrence rate in both arms
|
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Benign breast diseases are a heterogenous group of disorder affecting women. One of the entity of this group is intraductal papilloma (IDP) which can present as nipple discharge or rarely remain asymptomatic. IDP are associated with a small increase in risk of malignancy. The treatment of IDP is by surgical excision either by major duct excision or microdochectomy, depending on age of the lady and completion of family size. Traditional teaching advocated excision with 5 cm length of ducts being excised. Extensive dissection beneath the nipple can lead to nipple necrosis, nipple anaesthesia and nipple retraction. Since many papilloma are located within 2 cm of duct from the nipple, few surgeons now recommend removal of ducts with 2.5 cm extent, which can reduce the amount of dissection and hence the associated complications. |