跳至主要内容
临床试验/CTRI/2015/11/006398
CTRI/2015/11/006398招募中不适用

A Randomized control trial comparing the impact of Hepatic Artery and Portal Vein flushing versus Portal Vein flushing alone in Live Donor Liver Transplant patients, on the immediate and long term graft function.

Amrita Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年10月7日
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Early and late biliary complications.

研究概览

简要总结

Thisis a Randomized, Parallel Group, Multiple Arm, Singlecentre study to study the impact of flushing the Hepatic Artery of the LiverGraft, on the immediate and long term graft function.  The primaryobjective of the study is to determine whether thesaid procedure helps in reducing the incidence of post-operative biliarycomplications.

InDeceased Donor Liver Transplantation it is routine to flush all vesselsincluding the Hepatic artery with cold preservative solution during theretrieval operation and at bench work Procedures (1). But in LDLT flushing of the Hepatic artery on the back table is notroutine. Historically many surgeon never advocated flushing of the artery withpreservative solution due to the fear of damaging the intima of the hepaticartery, probably due to the small size of the artery and due to the alreadyincreased risk of vasculo-biliary complications.  Another reason for notflushing the artery could be markedly shorter cold ischaemia time (CIT) in LDLT (2). However, some authorsadvocate routine formal HA flush on the back table, on the basis that it isadvantageous as long as intimal damage to the HA can be prevented (3, 4, 5).

One ofthe most common complications encountered in patients who have undergone LDLTis biliary complications. The incidence of biliary complications has beenreported to be 0.4% to 13.0% (6).The biliary complications mayinvolve either the anastomosis created with the biliary tree or may involve anyother portion of the biliary tree. Diffuse biliary strictures (7), ischemic-type biliary strictures (8),ischemic cholangitis (9),intra-hepatic biliary strictures (10),non-anastomotic strictures and anastomotic strictures have been reported. Theetiology of these lesions appeared to be mostly related to ischemic injury. Onmany occasions, the process of liver transplantation exposes the endothelialcells to injury (11).Cold preservation injury, reperfusion injury, and immunological injury canhappen in the course of liver transplantation (12). These endothelial injuries may causehepatic arteriopathy, vasoconstriction, and microvascular thrombosis.Unequivocally, the incidence of Ischaemic Type Biliary Strictures aresignificantly less in grafts with short cold ischemia times.

Thebiliary tract is supplied with arterial blood by a vasculature called theperibiliary vascular plexus (12). Arterial supply of the biliary tree is fromthe Hepatic artery and venous drainage goes into the portal vein. Few studieshave reported reduced post-operative biliary complications especially IschaemicType Biliary Strictures with arterial flushing. But almost all studies havebeen performed in DDLT recipients. Atpresent the data available is not sufficient to employ Hepatic Artery flushingas a standard procedure in all patients undergoing LDLT, although many authors employ it routinely (3, 4, 5).  As the Hepatic Arterysupplies the biliary tree, flushing of the Hepatic artery with preservationsolution could reduce the ischaemia to the biliary tree and could possibly helpin reducing the biliary complications in the post-operative period.

Wehypothesize that Hepatic Artery flushing in addition to flushing the PortalVein on the back table with HTK solution(Cold Preservative Solution) couldreduce the incidence of post-operative biliary complications.

 References

1. *Typeof donor aortic preservation solution and not cold ischemic time is a majordeterminant of biliary strictures after liver transplantation.*Pirenne J, Van Gelder F, CoosemansW et al. 540, s.l. : Liver Transpl 2001: 7:, 2001, Vol. 7.

2. *Technicalrefinement in adult-to-adult living donor liver transplantation using rightlobe graft.*Fan ST, Liu CL.126, s.l. : Ann Surg, 2000, Vol. 231.

3. *Histidine–tryptophan–ketoglutarateversus university of Wisconsin solution in living donor liver transplantation:results of a prospective study.*TestaG, Malago M, Nadalin S et al. 822, s.l. : Liver Transpl, 2003, Vol. 9.

4. *Adultliving donor liver transplantation using a right hepatic lobe. Transplantation.*Wachs ME, Bak TE, Karrer FM et al.s.l. : Transplantation, 1998, Vol. 66: 1313.

5. *Donorhepatectomy for living related partial liver transplantation.*Makuuchi M, Kawasaki S, Noguchi Tet a. s.l. : Surgery , 1993, Vol. 113: 395.

6. *BiliaryComplications After Living Donor Liver Transplantation.*Shao Fa Wang, Zhi Yong Huang, andXiao Ping Chen. s.l. : LIver Transplantation, 2011, Vols. 17:1127-1136.

7. *Diagnosticfeatures and clinical outcome of ischemic- type biliary complications afterliver transplantation.*Sanchez-UrdazpalL, Gores GJ, Ward EM, Maus TP, Buckel EG, Steers JL, et al. c. s.l. : Hepatology, 1993, Vols. 17:605–9.

8. *Diffusebiliary tract injury after orthotopic liver transplantation. .*Li S, Stratta RJ, Langnas AN, WoodRP, Marujo W, Shaw BW. s.l. : Am J Surg , 1992, Vols. 164:536–40.

9. *Ischemiccholangitis in hepatic allografts. Mayo Clin Proc 1992;67:519–26.*Ludwig J, Batts KP, MacCarty R.s.l. : Mayo Clin Proc 1992;67:519–26., 1992, Vols. 67:519–26.

10. *Intrahepaticbiliary strictures without hepatic artery thrombosis after livertransplantation: an analysis of 1113 liver transplantations at a single center..*Nakamura N, Nishida S, NeffGR, Vaidya A, Levi DM, Kato T, et al. s.l. : Transplantation , 2005, Vols.79:427–32.

11. *Ischemic-typebiliary strictures in liver allografts: the Achilles heel revisited?*Fisher A, Miller CM. s.l. :Hepatology, 1995, Vols. 21:589–91.

12. *Intrahepaticbiliary strictures after liver transplantation.*Seigo Nishida, Noboru Nakamura,Jun Kadono, Teruo Komokata, Ryuzo Sakata, Juan R. Madariaga. s.l. : JHepatobiliary Pancreat Surg, 2006, Vols. 13:511–516.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Open Label

入排标准

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

入选标准

  • •All consenting patients undergoing Live Donor Liver Transplantation.

排除标准

  • •ABO Incompatible Liver Transplants.

结局指标

主要结局

Early and late biliary complications.

时间窗: Post operative period to the last follow up date.

2. Biliary Stricture

时间窗: Post operative period to the last follow up date.

1. Biliary Leak

时间窗: Post operative period to the last follow up date.

次要结局

  • Intra operative Haemodynamic parameters - The parameters of intra-operative hemodynamic changes measured includes the measurement of Post Reperfusion Syndrome.(Intra operative)
  • Vascular Complications – vascular complications includes stenosis or occlusion of the anastomoses of the Hepatic artery, Portal vein and Hepatic vein which required surgical or radiological interventions or has been demonstrated by any imaging modality.(In the post operative period.)
  • Liver Function Tests measured immediately post-transplant and on the Post Op Day 1, Day 3, Day 7, Day 14 and 1 month.(Post operative days as mentioned)
  • Length of post-operative hospital stay.(Total Hospital stay)
  • Post-operative graft and patient survival rates.(Long term graft and patient survival figures up to the last follow up.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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