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临床试验/CTRI/2024/06/068400
CTRI/2024/06/068400尚未招募2/3 期

Role of Platelet Rich Fibrin (PRF) in Pancreatico-Jejunostomy in patients undergoing Pancreatoduodenectomy – A Randomized Controlled Trial

Amrita Institute of Medical Sciences, Kochi1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
To compare the incidence of Post-operative Biochemical Leak (as per ISGPS Definition) after using PRF on PJ Anastomosis versus no intervention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing pancreatico-duodenectomy for any indication
  • Good PRF Formation after centrifuge.

排除标准

  • Pediatric patients
  • Non-consenting patients
  • Poor PRF formation.

结局指标

主要结局

To compare the incidence of Post-operative Biochemical Leak (as per ISGPS Definition) after using PRF on PJ Anastomosis versus no intervention

时间窗: Post op Day 3

次要结局

  • Difference in overall outcomes by length of hospital stay, ICU stay, complications, mortality(3 months)

研究者

发起方
Amrita Institute of Medical Sciences, Kochi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Atish Parikh

Amrita Institute of Medical Sciences, Kochi

研究点 (1)

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