| 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
|
|
|
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
|
|
|
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. |