| CTRI Number |
CTRI/2019/05/019347 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
23/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two techniques of breast cancer excision for nonpalpable breast lesions. |
|
Scientific Title of Study
|
Comparision of wire guided lumpectomy versus sonographic hematoma guided lumpectomy in management of nonpalpable breast cancers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamal Kataria |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No - 5025, Vth Floor, Teaching Block, Department of Surgical Disciplines
All India Institute of Medical Sciences
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9212678920 |
| Fax |
|
| Email |
drkamalkataria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Kataria |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No - 5025, Vth Floor, Teaching Block, Department of Surgical Disciplines
All India Institute of Medical Sciences
New Delhi - 110029
DELHI
110029
India |
| Phone |
9212678920 |
| Fax |
|
| Email |
drkamalkataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Kataria |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No - 5025, Vth Floor, Teaching Block, Department of Surgical Disciplines
All India Institute of Medical Sciences
New Delhi - 110029
DELHI
110029
India |
| Phone |
9212678920 |
| Fax |
|
| Email |
drkamalkataria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research section, AIIMS, Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Delhi |
| Address |
All India Institute of Medical Sciences, Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kamal Kataria |
AIIMS, Delhi |
Department Of Surgical Disciplines
South
DELHI |
9212678920
drkamalkataria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sonographic hematoma guided lumpectomy for breast cancer |
Sonographic hematoma guided lumpectomy for breast cancer seems better than wire guided excision of nonpalpable breast cancers
(single one time intervention) |
| Comparator Agent |
wire guided lupectomy for nonpalpable breast cancer |
Sonographic hematoma guided lumpectomy for breast cancer seems better than wire guided excision of nonpalpable breast cancers
(single one time intervention) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Nonpalpable BIRADS 4 or BIRADS 5 breast lesions
2. All women above the age of 18 years with histopathologically proved nonpalpable breast cancer.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reoperation Rates |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cost benefit analysis
Patient satisfaction |
2 years |
|
|
Target Sample Size
|
Total Sample Size="262"
Sample Size from India="262"
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)
|
01/06/2019 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
goal of breast conservation therapy for breast cancer is to achieve an
oncologic resection with adequate margins while maintaining cosmesis. This
poses significant challenges in the case of nonpalpable lesions and requires
image-guided localization to effect resection. The current standard technique
of operative guidance is preoperative wire localization, which is associated
with several limitations. Smith et al, described the use of the sonographically
visible hematoma (induced iatrogenically) as a localizing device with intraoperative
ultrasonography. We hypothesized that sonographic hematoma-guided (SHG)
lumpectomy for breast cancer is better than wire guided excision.
|