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CTRI Number  CTRI/2024/06/068400 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
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   Role of Platelet Rich Fibrin in healing of Pancreatic Anastomosis 
Scientific Title of Study   Role of Platelet Rich Fibrin (PRF) in Pancreatico-Jejunostomy in patients undergoing Pancreatoduodenectomy – A Randomized Controlled Trial 
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 Atish Parikh 
Designation  MCh Resident 
Affiliation  Amrita Institute of Medical Sciences, Kochi 
Address  Department of GI Surgery Amrita Hospital, Ponekkara Road PO, Edappally, Kochi

Ernakulam
KERALA
682041
India 
Phone  9920028474  
Fax    
Email  atishparikh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atish Parikh 
Designation  MCh Resident 
Affiliation  Amrita Institute of Medical Sciences, Kochi 
Address  Department of GI Surgery Amrita Hospital, Ponekkara Road PO, Edappally, Kochi

Ernakulam
KERALA
682041
India 
Phone  9920028474  
Fax    
Email  atishparikh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudhindran S 
Designation  Professor 
Affiliation  Amrita Institute of Medical Sciences, Kochi 
Address  Room No. 4 Department of GI Surgery, Amrita Hospital, Ponekkara Road PO, Edappally, Kochi

Ernakulam
KERALA
682041
India 
Phone  9388623851  
Fax    
Email  sudhisalini@icloud.com  
 
Source of Monetary or Material Support  
Amrita Institute of Medical Sciences, Ponekkara Road PO, Edappally, Ernakulam 682041, Kerala, India 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences, Kochi 
Address  Ponekkara Road PO, Edappally, Kochi 682041, Ernakulam, Kerala 
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 Atish Parikh  Amrita Institute of Medical Sciences  Amrita Hospital, Ponekkara Road PO, Edappally, Kochi 682041
Ernakulam
KERALA 
9920028474

atishparikh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Amrita Institute of Medical Sciences  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  No PRF  Standard reconstruction technique without additional PRF 
Intervention  Platelet Rich Fibrin  Autologous Platelet Rich Fibrin wrapped around pancreatic anastomosis after reconstruction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients undergoing pancreatico-duodenectomy for any indication
2. Good PRF Formation after centrifuge 
 
ExclusionCriteria 
Details  1. Pediatric patients
2. Non-consenting patients
3. Poor PRF formation  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of Post-operative Biochemical Leak (as per ISGPS Definition) after using PRF on PJ Anastomosis versus no intervention  Post op Day 3 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in overall outcomes by length of hospital stay, ICU stay, complications, mortality  3 months 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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/ Phase 3 
Date of First Enrollment (India)   15/06/2024 
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 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  

Platelet rich fibrin (PRF) is a new generation of platelet concentrates. It was first developed by Choukrroun et al in France for use in maxillofacial surgery. It is an autologous bio-scaffold which can be prepared easily and does not require biochemical manipulation. It contains fibrin, leukocytes, cytokines and growth factors which are known to accelerate tissue healing. The coagulum acts as a reservoir for growth factors which promote neovascularization, increased wound closing with fast cicatricial tissue re-modelling and reduction of infectious events.

Its use in clinical practice is manifold with majority published clinical use in oro-maxillofacial, orthopaedicians, cardiothoracic, plastic surgery and dermatology. 

Experimental models have demonstrated significant benefits in rat, porcine and rabbit models for intestinal anastomosis, colonic anastomosis, airway anastomosis and even dura mater closure.

POPF remains the single main determinant of serious postoperative morbidity and mortality related to pancreatic resection and plays a major role in terms of operation-related mortality, morbidity, hospital stay, and economic impact. Despite all the advances and technical modifications developed during this past decade to prevent POPF, the incidence of this dreaded complication still ranges between 3–45 % of pancreatic operations at high volume centers.

The use of PRF on Pancreatic Anastomosis has not been evaluated in human studies yet. PRF is routinely being used in various other surgeries including at our centre in wound related issues, complex fistulas and joint related issues with favourable results. Our unit currently has an ongoing study on the effects of PRF on Bile Duct Anastomosis in LDLT. No complications have been reported so far.

With this background, we want to conduct this study for evaluation of the role of PRF in Pancreatic anastomosis. 

 
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