Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation

NCT04252794 | Completed

• 1 other identifier: ILBS-Liver Transplant-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators aim to prove that performing graft inflow modulation (GIM) in liver with portal hyper-perfusion is beneficial for early graft function postoperatively. Grafts at risk for portal hyper-perfusion will be identified by doing an intraoperative Doppler after reperfusion. In group A, the investigators will take 21 liver transplant recipients after reperfusion, randomly allocated, who will undergo intraoperative graft inflow modulation by splenic artery ligation. In group B, the investigators will be analyzing another randomly allocated 21 patients, who will not undergo any graft inflow modulation. The investigators will be analyzing trend of LFT's (liver function tests) after surgery, time for normalization of bilirubin, INR (international normalised ratio) and decrease in ascites, morbidity, mortality, ICU (intensive care unit) and total hospital stay.

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Incidence of early graft dysfunction

  Number of patients who develop early graft dysfunction in each group

  first postoperative month

Secondary Outcomes (7)

• Time to normalisation of bilirubin

  first postoperative month

• Time to normalisation of INR

  first postoperative month

• Time to normalisation of ascites output

  first postoperative month

• Morbidity

  first postoperative month

• ICU stay

  first operative month

Study Arms (2)

Patients who undergo GIM

EXPERIMENTAL

If inclusion criteria are met, after randomisation, these group of patients will undergo splenic artery ligation (graft inflow modulation)

Procedure: Splenic artery ligation

No splenic artery ligation

ACTIVE COMPARATOR

If inclusion criteria are met, after randomisation, these group of patients will not undergo splenic artery ligation (graft inflow modulation)

Other: No intervention

Interventions

Splenic artery ligation PROCEDURE

Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas

Patients who undergo GIM

No intervention OTHER

Splenic artery is not ligated despite the presence of portal hyperperfusion

No splenic artery ligation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Portal Venous Pressure (PVP) \> 15 mm Hg after reperfusion or
• Portal venous flow (PVF) \> 250 ml/min/100 gr of liver after reperfusion with a gradient (PVP - CVP) of ≥ 7 mm Hg

You may not qualify if:

• Significant peripancreatic collaterals preventing safe access to splenic artery
• Acute Liver Failure as an indication for transplant
• ABO incompatible transplants
• Pediatric transplants
• Refusal to participate in the study

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, 110074, India

Location

Related Publications (15)

• Kiuchi T, Kasahara M, Uryuhara K, Inomata Y, Uemoto S, Asonuma K, Egawa H, Fujita S, Hayashi M, Tanaka K. Impact of graft size mismatching on graft prognosis in liver transplantation from living donors. Transplantation. 1999 Jan 27;67(2):321-7. doi: 10.1097/00007890-199901270-00024.

  PMID: 10075602 RESULT

• Bell R, Pandanaboyana S, Upasani V, Prasad R. Impact of graft-to-recipient weight ratio on small-for-size syndrome following living donor liver transplantation. ANZ J Surg. 2018 May;88(5):415-420. doi: 10.1111/ans.14245.

  PMID: 29752783 RESULT

• Vasavada BB, Chen CL, Zakaria M. Portal flow is the main predictor of early graft dysfunction regardless of the GRWR status in living donor liver transplantation - a retrospective analysis of 134 patients. Int J Surg. 2014;12(2):177-80. doi: 10.1016/j.ijsu.2013.12.006. Epub 2013 Dec 25.

  PMID: 24370677 RESULT

• Vasavada B, Chen CL, Zakaria M. Using low graft/recipient's body weight ratio graft with portal flow modulation an effective way to prevent small-for-size syndrome in living-donor liver transplant: a retrospective analysis. Exp Clin Transplant. 2014 Oct;12(5):437-42.

  PMID: 25299370 RESULT

• Lei JY, Yan LN, Li B, Wen TF, Wang WT, Xu MQ, Yang JY. Graft size alone should not affect donors selection and be used to predict the prognosis of recipients after living donor liver transplantation. Hepatogastroenterology. 2012 Jan-Feb;59(113):224-7. doi: 10.5754/hge11035.

  PMID: 22260833 RESULT

• Demetris AJ, Kelly DM, Eghtesad B, Fontes P, Wallis Marsh J, Tom K, Tan HP, Shaw-Stiffel T, Boig L, Novelli P, Planinsic R, Fung JJ, Marcos A. Pathophysiologic observations and histopathologic recognition of the portal hyperperfusion or small-for-size syndrome. Am J Surg Pathol. 2006 Aug;30(8):986-93. doi: 10.1097/00000478-200608000-00009.

  PMID: 16861970 RESULT

• Shimamura T, Taniguchi M, Jin MB, Suzuki T, Matsushita M, Furukawa H, Todo S. Excessive portal venous inflow as a cause of allograft dysfunction in small-for-size living donor liver transplantation. Transplant Proc. 2001 Feb-Mar;33(1-2):1331. doi: 10.1016/s0041-1345(00)02496-9. No abstract available.

  PMID: 11267312 RESULT

• Ou HY, Huang TL, Chen TY, Tsang LL, Chen CL, Cheng YF. Early modulation of portal graft inflow in adult living donor liver transplant recipients with high portal inflow detected by intraoperative color Doppler ultrasound. Transplant Proc. 2010 Apr;42(3):876-8. doi: 10.1016/j.transproceed.2010.02.064.

  PMID: 20430194 RESULT

• Ogura Y, Hori T, El Moghazy WM, Yoshizawa A, Oike F, Mori A, Kaido T, Takada Y, Uemoto S. Portal pressure <15 mm Hg is a key for successful adult living donor liver transplantation utilizing smaller grafts than before. Liver Transpl. 2010 Jun;16(6):718-28. doi: 10.1002/lt.22059.

  PMID: 20517905 RESULT

• Wang H, Ikegami T, Harada N, Yoshizumi T, Soejima Y, Uchiyama H, Yamashita Y, Itoh S, Harimoto N, Kawanaka H, Shirabe K, Maehara Y. Optimal changes in portal hemodynamics induced by splenectomy during living donor liver transplantation. Surg Today. 2015 Aug;45(8):979-85. doi: 10.1007/s00595-014-0999-9. Epub 2014 Aug 2.

  PMID: 25080864 RESULT

• Luca A, Miraglia R, Caruso S, Milazzo M, Gidelli B, Bosch J. Effects of splenic artery occlusion on portal pressure in patients with cirrhosis and portal hypertension. Liver Transpl. 2006 Aug;12(8):1237-43. doi: 10.1002/lt.20762.

  PMID: 16741929 RESULT

• Osman AM, Hosny AA, El-Shazli MA, Uemoto S, Abdelaziz O, Helmy AS. A portal pressure cut-off of 15 versus a cut-off of 20 for prevention of small-for-size syndrome in liver transplantation: A comparative study. Hepatol Res. 2017 Mar;47(4):293-302. doi: 10.1111/hepr.12727. Epub 2016 May 11.

  PMID: 27084787 RESULT

• Troisi R, de Hemptinne B. Clinical relevance of adapting portal vein flow in living donor liver transplantation in adult patients. Liver Transpl. 2003 Sep;9(9):S36-41. doi: 10.1053/jlts.2003.50200.

  PMID: 12942477 RESULT

• Yamada T, Tanaka K, Uryuhara K, Ito K, Takada Y, Uemoto S. Selective hemi-portocaval shunt based on portal vein pressure for small-for-size graft in adult living donor liver transplantation. Am J Transplant. 2008 Apr;8(4):847-53. doi: 10.1111/j.1600-6143.2007.02144.x. Epub 2008 Feb 5.

  PMID: 18261170 RESULT

• Umeda Y, Yagi T, Sadamori H, Matsukawa H, Matsuda H, Shinoura S, Mizuno K, Yoshida R, Iwamoto T, Satoh D, Tanaka N. Effects of prophylactic splenic artery modulation on portal overperfusion and liver regeneration in small-for-size graft. Transplantation. 2008 Sep 15;86(5):673-80. doi: 10.1097/TP.0b013e318181e02d.

  PMID: 18791439 RESULT

Related Links

• Hemodynamic interaction between portal vien and hepatic artery flow in small-for-size split liver transplantation - Smyrniotis - 2002 - Transplant International - Wiley Online Library

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gattu Tharun, MS

  Senior resident, Department of HPB surgery, ILBS, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, HPB Surgery

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: February 5, 2020
• Study Start: August 8, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)