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CTRI Number  CTRI/2024/07/070043 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing surgery outcomes with and without pre-surgery blocking of splenic artery in patients with enlarged spleens 
Scientific Title of Study   An open label randomized control trial to compare the outcomes with and without preoperative splenic artery embolization SAE in patients with moderate splenomegaly undergoing elective laparoscopic splenectomy undergoing elective laparoscopic splenectomy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti Sharma 
Designation  Senior Resident 
Affiliation  AIIMS Delhi 
Address  Room no 311, 3rd floor, Department of Surgical disciplines, Surgery block, AIIMS Delhi

New Delhi
DELHI
110029
India 
Phone  8860314670  
Fax    
Email  js130193@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Yashwant Singh Rathore 
Designation  Additional Professor 
Affiliation  AIIMS Delhi 
Address  Room no 429, 4th floor, Department of Surgical disciplines, Surgery block, AIIMS Delhi

New Delhi
DELHI
110029
India 
Phone  9911337726  
Fax    
Email  dryashvant.r@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jyoti Sharma 
Designation  Senior Resident 
Affiliation  AIIMS Delhi 
Address  Room no 311, 3rd floor, Department of Surgical disciplines, surgery block, AIIMS Delhi

New Delhi
DELHI
110029
India 
Phone  8860314670  
Fax    
Email  js130193@gmail.com  
 
Source of Monetary or Material Support  
Department of surgical disciplines, Surgery block, All India Institute of Medical Sciences, Delhi, India, 110029 
 
Primary Sponsor  
Name  Jyoti Sharma 
Address  Room No 311, 3rd floor,Surgery block, All India Institute of Medical Sciences,Delhi, India, 110029 
Type of Sponsor  Other [Self] 
 
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 Jyoti Sharma  All India Institute of Medical Sciences, Delhi  Room no 311, 3rd floor, Department of Surgical disciplines, Surgery block, All India Institute of Medical Sciences, Delhi, India
New Delhi
DELHI 		 8860314670

js130193@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post graduate Research,AIIMS Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laparoscopic splenectomy  Patients undergoing elective laparoscopic splenectomy for moderate splenomegaly. The duration of surgery cannot be defined as it varies according to the surgeon and intra operative difficulty.  
Intervention  Pre operative Splenic artery embolization  Preoperative splenic artery embolization in patients undergoing elective laparoscopic splenectomy for moderate splenomegaly, either the same day of surgery or one day before the surgery  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. All patients above 15 years of age undergoing elective splenectomy.
2. Patients giving informed consent.
3. Moderate splenomegaly.
 
 
ExclusionCriteria 
Details  1. Patients with portal hypertension
2. Severe cardiopulmonary disease
3. Traumatic spleen
4. Liver cirrhosis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Median operative time
2. Intra operative blood loss
3.Conversion to open surgery 		 1 week, 4 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Length of hospital stay, development of spleno-portal thrombosis and clinical response after splenectomy.   1 week, 4 weeks, 3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   16/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included js130193@gmail.com).

  6. For how long will this data be available start date provided 26-06-2024 and end date provided 28-06-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

There is meagre evidence comparing the effect of pre operative splenic artery embolisation (SAE) with laparoscopic splenectomy (LS) alone in patients with splenomegaly. While no indication exists in mild splenomegaly, various studies have demonstrated a positive result of pre operative SAE before elective LS in patients with moderate and massive splenomegaly. This includes lesser intra operative blood loss, lesser transfusion rates and reduction in splenic size, facilitating better handling of spleen during surgery. However, the current evidence mainly comprises of observational studies with a small sample size and no experimental studies are available.

The current SAGES guidelines suggest that pre operative SAE before laparoscopic splenectomy in patients with splenomegaly should be the surgeon and patient’s shared decision and is based on low certainty evidence. Thus, this randomized control trial aims to establish the certainty and feasibility of pre operative SAE before laparoscopic splenectomy in cases of moderate splenomegaly.

 
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