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CTRI Number  CTRI/2024/12/077661 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of Oncoplastic and Conventional breast surgery 
Scientific Title of Study   Comparison of Oncological and Cosmetic Outcomes in patients undergoing Oncoplastic vs Conventional (non-Oncoplastic) Breast Conservation Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Agarwal 
Designation  Professor 
Affiliation  SGPGI 
Address  Department of Endocrine Surgery, SGPGI Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904646  
Fax    
Email  gaurav@agpgi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Gaurav Agarwal 
Designation  Professor 
Affiliation  SGPGI 
Address  Department of Endocrine Surgery, SGPGI Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904646  
Fax    
Email  gaurav@agpgi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Mithlesh Wanchoo 
Designation  Senior Resident 
Affiliation  SGPGI 
Address  Department of Endocrine Surgery, SGPGI Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9419255052  
Fax    
Email  drmithleshw@gmail.com  
 
Source of Monetary or Material Support  
SGPGI, LUCKNOW 
 
Primary Sponsor  
Name  SGPGI LUCKNOW 
Address  Rae barelli road, Lucknow - 226014 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mithlesh wanchoo  SGPGI  Department of Endocrine Surgery, SGPGI Lucknow
Lucknow
UTTAR PRADESH 
9419255052

drmithleshw@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, SGPGI, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1 Female patients diagnosed with early breast cancer (EBC) or locally advanced breast cancer (LABC) who have undergone breast conservation surgery at SGPGIMS.
2 Patients who are candidates for breast-conserving surgery (BCS), either as primary surgery or after neoadjuvant chemotherapy (NACT).
3 Patients who consent to participate in the study and complete the required questionnaires.
 
 
ExclusionCriteria 
Details  •Patients with Metastatic Breast cancer
•Patients requiring mastectomy due to tumor size, multifocality, extensive microcalcifications, or any other clinical factors
•Insufficient data or follow up
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Margin infiltrating rate (MIR) i.e, positive margins on Frozen section biopsy between both groups
To compare Ipsilateral breast tumor recurrence (IBTR) rate between both groups.
 
At surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare patient satisfaction regarding breast shape, volume, symmetry, scar and overall satisfaction
To compare the re-excision rate between both groups
To estimate Overall Survival (OS) and disease-free survival rates (DFS)
To evaluate rate of conversion to mastectomy between both groups
 
6 months for Patient satisfaction and during follow up period 
 
Target Sample Size   Total Sample Size="376"
Sample Size from India="376" 
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)   14/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/12/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Breast cancer is among the most prevalent malignancies affecting women worldwide. Breast conservation  surgery(BCS) is the preferred surgical treatment combined with radiation therapy for eligible early(EBC) and selected locally advanced breast cancer(LABC) patients (1). Achieving sound oncologic outcomes are of paramount importance. Preserving quality of life is pivotal too, with maintaining breast symmetry, shape, contour being crucial objectives. Oncoplastic breast surgery(OPS) techniques are believed to help achieving these goals to greater extent than conventional non-oncoplastic(nOPS) BCS (2).

After neoadjuvant chemotherapy (NACT), breast conservation surgery (BCS) remains a safe option even for large tumors and locally advanced breast cancer (LABC), although many patients may require oncoplastic procedures to achieve satisfactory cosmetic results (3). In settings where patients commonly present with large breast cancers or LABC, the benefits of BCS can be extended to a majority, aided by NACT, without compromising cure rates. Performing a post-NACT wide local excision (WLE) that extends beyond the marked pre-NACT margins can result in clear, uninfiltrated margins in 95% of cases. Conversely, relying on post-NACT margins alone to guide WLE may lead to infiltrated margins in 35% of patients, some of which could remain undetected, thereby increasing the risk of local recurrence (4). A novel method using sterile silver wire markers to delineate tumor margins has proven to be a safe, cost-effective, and practical approach, facilitating safe BCS in a substantial proportion of LABC patients. Additionally, the use of intraoperative frozen section histology (IFSH) enables oncologically complete BCS in a single step for most patients, offering significant cost savings by reducing the need for reoperations, and minimizing patient anxiety and delays in adjuvant treatment (5).

 REFERENCES:

1.      Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33.

2.       Morrow M, Li Y, Alderman AK, Jagsi R, Hamilton AS, Graff JJ, et al. Access to breast reconstruction after mastectomy and patient perspectives on reconstruction decision making. JAMA Surg. 2014;149(10):1015-21.

1.      Agarwal G, Sonthineni C, Mayilvaganan S, Mishra A, Lal P, Agrawal V. Surgical Outcomes of Primary Versus Post-Neoadjuvant Chemotherapy Breast Conservation Surgery: A Comparative Study from a Developing Country. World J Surg. 2018 May;42(5):1364-74.

2.      Aggarwal V, Agarwal G, Lal P, Krishnani N, Mishra A, Verma AK, Mishra SK. Feasibility study of safe breast conservation in large and locally advanced cancers with use of radiopaque markers to mark pre-neoadjuvant chemotherapy tumor margins. World J Surg. 2008 Dec;32(12):2562-9.

3.      Agarwal G, Sattavan S, Vishvak Chanthar KMM, Kumar A, Sabaretnam M, Chand G, Mishra A, Agrawal V. Cost-Efficacy Analysis of Use of Frozen Section Histology for Margin Assessment During Breast Conservation Surgery in Breast Cancer Patients. World J Surg. 2023 Oct;47(10):2457-63


 
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