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CTRI Number  CTRI/2024/10/075086 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Surgical Intervention]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To study the benefit of addition of drainage of lymph fluid from arm to vein in prevention of swelling of arm (lymphedema) in patients undergoing removal of nodes from armpit in Breast Carcinoma. 
Scientific Title of Study   A Randomised trial to study the outcome of addition of Lymphatico-venous Anastomosis to standard of care for prevention of upper extremity Lymphedema in patients undergoing Axillary Lymph Node Dissection for Carcinoma Breast as compared to standard of care only. 
Trial Acronym  Nil 
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, New Delhi 
Address  Room no 430, Department of Surgical Disciplines, Surgery Block, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Dhar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 430, Department of Surgical Disciplines, Surgery Block, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddhant Karan 
Designation  Senior Resident (Acad) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 430, Department of Surgical Disciplines, Surgery Block, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9622211150  
Fax    
Email  siddhantkaran@yahoo.in  
 
Source of Monetary or Material Support  
Department of Surgical Disciplines, AIIMS, New Delhi 
 
Primary Sponsor  
Name  Department of Surgical Disciplines 
Address  AIIMS, Ansari Nagar, New Delhi, 110029 
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 Anita Dhar  AIIMS, New Delhi  Room no 430, Department of Surgical Disciplines,AIIMS, Ansari Nagar, New Delhi
South
DELHI 		 9810198239

dranitadharbhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  ALND  We will perform ALND only and follow up with standard of care 
Intervention  ALND + Lymphatico-venous Anastomosis   We will add Lymphatico-venous anastomosis to patients undergoing ALND and follow up with standard of care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  All female patients planned for ALND whether post NACT or in upfront setting. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the presence of Lymphedema of upper limb on the operated side at 6 months.

 		 2 weeks, 4 weeks, 8 weeks, 16 weeks, 20 weeks and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of quality of life by EORTC questionnaire C30/+BR23.
2. Surgical site infection
3. Development of seroma
4. Arm and shoulder pain
5. Anaesthesia/paraesthesia of inner side of arm and/ or chest wall
6. Episodes of cellulitis and DLA in the operated upper limb. 		 2 weeks, 4 weeks, 8 weeks, 16 weeks, 20 weeks and 6 months 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   Phase 4 
Date of First Enrollment (India)   15/10/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

MRM involves the removal of axillary lymph nodes, disrupting the normal lymphatic drainage system of the arm and breast. There are common channel lymphatics draining axilla and upper arm. This leads to Lymphedema.

Lymphedema can significantly impact a patient’s quality of life, causing discomfort, functional impairment, and psychological distress.

There are existing strategies for lymphedema prevention, such as lymphatic drainage techniques and compression therapy.

Lymphatico-venous Anastomosis (LVA) involves connecting lymphatic vessels directly to nearby veins, which may help to establish alternative drainage pathways for lymph fluid, thereby reducing the risk of lymphedema.
 
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