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CTRI Number  CTRI/2015/11/006398 [Registered on: 30/11/2015] Trial Registered Retrospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study comparing the effect of Hepatic Artery Flushing with cold Preservative solution in Liver Transplant. 
Scientific Title of Study   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. 
Trial Acronym  HALT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudhindran S 
Designation  Professor 
Affiliation  Amrita Institute Of Medical Sciences 
Address  Department of Abdominal Transplant, GI Surgery & Vasculr Surgery, Amrita Institute Of Medical Sciences, Ponekkara

Ernakulam
KERALA
682041
India 
Phone  04844001234  
Fax    
Email  sudhi@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Johns Shaji Mathew 
Designation  Resident  
Affiliation  Amrita Institute Of Medical Sciences 
Address  Department of Abdominal Transplant, GI Surgery & Vasculr Surgery, Amrita Institute Of Medical Sciences, Ponekkara

Ernakulam
KERALA
682041
India 
Phone  9447348629  
Fax    
Email  johnssm20981@aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr Johns Shaji Mathew 
Designation  Resident  
Affiliation  Amrita Institute Of Medical Sciences 
Address  Department of Abdominal Transplant, GI Surgery & Vasculr Surgery, Amrita Institute Of Medical Sciences, Ponekkara

Ernakulam
KERALA
682041
India 
Phone  9447348629  
Fax    
Email  johnssm20981@aims.amrita.edu  
 
Source of Monetary or Material Support  
No Funding 
 
Primary Sponsor  
Name  Amrita Institute Of Medical Sciences 
Address  Ponekkara, Kochi, Kerala 682041 
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 Sudhindran S  Amrita Institute Of Medical Sciences  Ponekkara, Kochi, Kerala 682041
Ernakulam
KERALA 		 04844001234

sudhi@aims.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dissertation Protocol Review Committee(Scientific, Ethical & Financial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from Chronic Liver Disease who require Liver Transplant for survival.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hepatic Artery Perfusion and Portal Vein Perfusion  In addition to pefusion/flushing of the Portal Vein of the graft liver during the backtable preparation, the Hepatic Artery will also be perfused/flushed with a minimum of 300ml of HTK(Custodial) Solution or till the effluent becomes clear. HTK is a cold preservative solution used for organ preservation. For the Hepatic artery, an atraumatic straight Paediatric size cardioplegia catheter (without metal introducer) will be used for perfusion. Size of the cannula is 14F. The HTK solution bag will be placed inside a pressure infuser bag which will maintain a pressure not exceeding 150mm Hg. In the control group only the Portal Vein of the graft liver will be flushed.  
Comparator Agent  Portal Vein Perfusion only  In the control group only the portal vein will be perfused/flushed with HTK Solution.  
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All consenting patients undergoing Live Donor Liver Transplantation. 
 
ExclusionCriteria 
Details  ABO Incompatible Liver Transplants. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Early and late biliary complications.
1. Biliary Leak
2. Biliary Stricture 		 Post operative period to the last follow up date. 
 
Secondary Outcome  
Outcome  TimePoints 
Intra operative Haemodynamic parameters - The parameters of intra-operative hemodynamic changes measured includes the measurement of Post Reperfusion Syndrome.  Intra operative 
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 
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. 
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.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   10/07/2015 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Mentioned in the brief summary 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a Randomized, Parallel Group, Multiple Arm, Single centre study to study the impact of flushing the Hepatic Artery of the Liver Graft, on the immediate and long term graft function.  The primary objective of the study is to determine whether the said procedure helps in reducing the incidence of post-operative biliary complications. 

In Deceased Donor Liver Transplantation it is routine to flush all vessels including the Hepatic artery with cold preservative solution during the retrieval operation and at bench work Procedures (1). But in LDLT flushing of the Hepatic artery on the back table is not routine. Historically many surgeon never advocated flushing of the artery with preservative solution due to the fear of damaging the intima of the hepatic artery, probably due to the small size of the artery and due to the already increased risk of vasculo-biliary complications.  Another reason for not flushing the artery could be markedly shorter cold ischaemia time (CIT) in LDLT (2). However, some authors advocate routine formal HA flush on the back table, on the basis that it is advantageous as long as intimal damage to the HA can be prevented (3, 4, 5).

One of the most common complications encountered in patients who have undergone LDLT is biliary complications. The incidence of biliary complications has been reported to be 0.4% to 13.0% (6).The biliary complications may involve either the anastomosis created with the biliary tree or may involve any other 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. The etiology of these lesions appeared to be mostly related to ischemic injury. On many occasions, the process of liver transplantation exposes the endothelial cells to injury (11). Cold preservation injury, reperfusion injury, and immunological injury can happen in the course of liver transplantation (12). These endothelial injuries may cause hepatic arteriopathy, vasoconstriction, and microvascular thrombosis. Unequivocally, the incidence of Ischaemic Type Biliary Strictures are significantly less in grafts with short cold ischemia times.

The biliary tract is supplied with arterial blood by a vasculature called the peribiliary vascular plexus (12). Arterial supply of the biliary tree is from the Hepatic artery and venous drainage goes into the portal vein. Few studies have reported reduced post-operative biliary complications especially Ischaemic Type Biliary Strictures with arterial flushing. But almost all studies have been performed in DDLT recipients. At present the data available is not sufficient to employ Hepatic Artery flushing as a standard procedure in all patients undergoing LDLT, although many authors employ it routinely (3, 4, 5).  As the Hepatic Artery supplies the biliary tree, flushing of the Hepatic artery with preservation solution could reduce the ischaemia to the biliary tree and could possibly help in reducing the biliary complications in the post-operative period.

We hypothesize that Hepatic Artery flushing in addition to flushing the Portal Vein on the back table with HTK solution(Cold Preservative Solution) could reduce the incidence of post-operative biliary complications.

 

References

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

2. Technical refinement in adult-to-adult living donor liver transplantation using right lobe graft. Fan ST, Liu CL. 126, s.l. : Ann Surg, 2000, Vol. 231.

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

4. Adult living 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. Donor hepatectomy for living related partial liver transplantation. Makuuchi M, Kawasaki S, Noguchi T et a. s.l. : Surgery , 1993, Vol. 113: 395.

6. Biliary Complications After Living Donor Liver Transplantation. Shao Fa Wang, Zhi Yong Huang, and Xiao Ping Chen. s.l. : LIver Transplantation, 2011, Vols. 17:1127-1136.

7. Diagnostic features and clinical outcome of ischemic- type biliary complications after liver transplantation. Sanchez-Urdazpal L, Gores GJ, Ward EM, Maus TP, Buckel EG, Steers JL, et al. c. s.l. : Hepatology , 1993, Vols. 17:605–9.

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

9. Ischemic cholangitis 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. Intrahepatic biliary strictures without hepatic artery thrombosis after liver transplantation: an analysis of 1113 liver transplantations at a single center. . Nakamura N, Nishida S, Neff GR, Vaidya A, Levi DM, Kato T, et al. s.l. : Transplantation , 2005, Vols. 79:427–32.

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

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

 

 

 

 
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