Cirrhosis, LiverNCT04252794
Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation
A study testing Splenic artery ligation in people with Cirrhosis, Liver, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Splenic artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 8 Aug 2019to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation: a Randomized Pilot Study
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.
Read the detailed description
Due to shortage of deceased donor organs, LDLT (living donor living transplantation) is gaining importance all over world. Previous studies have showed poor outcomes with donor grafts having GRWR (graft to recipient weight ratio) < 0.8 due to development of SFSS (Small for Size Syndrome) where the graft is too small to meet the recipient's metabolic demands. SFSS is characterised by prolonged cholestasis, intractable ascites, prolonged INR and encephalopathy. However, it is not always possible to obtain larger graft from live donor owing to the risk's associated to donor. Various techniques have been developed in order to manage a smaller graft in recipient (ex: hemiportocaval shunts, splenic artery ligation, splenectomy). HPCS (hemiportocaval shunt) have been associated with risks of portal steal phenomenon and encephalopathy. Splenectomy is associated with increased risks of infections / sepsis and portal vein thrombosis postoperatively. Splenic artery ligation close to its origin is associated with least risks and is increasingly being used as the method of graft inflow modulation when required.
Recent studies have showed that Portal Flow Hemodynamics are more important than GRWR in predicting the occurrence of SFSS. Grafts whose GRWR is > 0.8 can also show features of SFSS after ruling out all other causes (5). Persistent portal hypertension leads to sinusoidal endothelial injury, haemorrhage, oedema and architectural distortion - these changes are more marked in SFS (small for size) grafts. Also, due to hepatic arterial buffer response, reduced flow in hepatic artery leads to further ischemic injury, cholestasis and ischemic cholangitis. A recipient portal venous flow of > 250 ml/min/100 grams of liver weight is defined as portal hyper perfusion.
H Y Ou et al retrospectively analysed data involving patients whose PVF > 250 ml/min/100 gr after reperfusion where 6 patients underwent inflow modulation (using splenic artery ligation) and other 2 didn't. They found that only 1 / 6 patients in those who underwent GIM developed SFSS where as both the patients who didn't undergo GIM developed SFSS (1 of them died). Also, none of the patients developed complications related to splenic artery ligation in their study.
Bhavin B et al in their retrospective study on 134 liver transplant recipients found that 19 patients met criteria for SFSS (as per Kyushu University). On analysis of the factors responsible for early graft dysfunction, only portal vein flow > 190 ml/min/100 gr of liver after reperfusion was found to be a significant predictor. GRWR was not significantly associated with graft dysfunction - 3 / 19 patients had GRWR < 0.8 while 16 patients in non-dysfunction group had GRWR < 0.8
Ogura et al retrospectively analysed data involving intentional portal pressure modulation when PVP (portal venous pressure) > 20 mm Hg. They found that the patients with a portal pressure < 15 mm Hg had better 2 year survival compared to those with > 15 mm Hg. Also, recovery from hyper bilirubinaemia and coagulopathy after transplantation was significantly better in those with PVP < 15 mm Hg.
Wang et al retrospectively analysed data involving 276 patients where they performed GIM by doing splenectomy (SPL) when PVP > 20 mm Hg. Group 1 had 134 patients who underwent SPL and Group 2 had 122 patients in whom GIM was not done. Graft compliance, Portal venous flow was significantly better in group 1 patients. Also, there was faster normalisation of bilirubin and ascites in group 1 when compared to group 2. Overall, 15.6 % patients had complications related to SPL - bleeding from splenic hilum, pancreatic leak, OPSS (overwhelming post spleenectomy sepsis) (1.9%).
Luca A et al in their study involving cirrhotic patients with portal hypertension, splenic artery occlusion causes a significant reduction in portal pressure gradient (PPG). This drop was indirectly related to liver volume and directly related to spleen volume. The spleen/liver volume ratio> 0.5 accurately predicts the drop in PPG and may be used to identify patients who can obtain a significant advantage from procedures decreasing splenic inflow.
Ayman et al had done a study wherethey aimed to keep final PVP < 20 mm Hg and analysed if PVP > 15 is a better predictor than PVP > 20 mm Hg for SFSS. Peak bilirubin, INR, incidence of post-transplant HE and SFSS was significantly higher in those with PVP of 15 - 19 mm Hg (group B) vs in those with PVP < 15 mm Hg (group A). 90 day morbidity and mortality was also significantly higher in Group B when compared to group A. On comparing grafts with GRWR < 0.8 with > 0.8, no significant differences in postoperative outcomes were seen.
Troisi et al did a retrospective study where they used Splenic artery ligation as the method of GIM when Recipient Portal Venous Flow was three times that of Donor portal vein flow. Group 1 had 11 patients with no GIM and group 2 had 13 patients who underwent GIM. SFSS occurred in three patients in Group 1 where all three needed re-transplantation whereas none of the patients in Group 2 developed SFSS. Also, One-year overallsurvival was 62% and 93% respectively for Group 1 and Group 2.
- Conditions
- Cirrhosis, Liver
- Being tested
- Splenic artery ligation, No intervention
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splenic artery ligationProcedure or surgery
Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
No interventionOther
Splenic artery is not ligated despite the presence of portal hyperperfusion
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo GIM | Experimental | If inclusion criteria are met, after randomisation, these group of patients will undergo splenic artery ligation (graft inflow modulation) Receives: 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early graft dysfunction
Number of patients who develop early graft dysfunction in each group
Measured: first postoperative month
Secondary outcomes (7)
Time to normalisation of bilirubin
time to normalisation of bilirubin (in days)
Measured: first postoperative month
Time to normalisation of INR
time to normalisation of INR (in days)
Measured: first postoperative month
Time to normalisation of ascites output
time to normalisation of ascites output (in days)
Measured: first postoperative month
Morbidity
Morbidity as per Clavein Dindo classfification
Measured: first postoperative month
ICU stay
Duration of ICU stay (in days)
Measured: first operative month
Mortality
death
Measured: first postoperative month
Total hospital stay
duration of total stay in hospital after liver transplatation (in days)
Measured: till 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Aug 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gattu Tharun, Institute of Liver and Biliary Sciences, India
- Investigators
- Gattu Tharun, MS, Principal investigator, Senior resident, Department of HPB surgery, ILBS, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252794
- Sponsor's protocol ID
- ILBS-Liver Transplant-02
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10075602Bell 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.
PubMed 29752783Vasavada 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.
PubMed 24370677Vasavada 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.
PubMed 25299370Lei 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.
PubMed 22260833Demetris 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.
PubMed 16861970Shimamura 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.
PubMed 11267312Ou 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.
PubMed 20430194Ogura 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.
PubMed 20517905Wang 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.
PubMed 25080864Luca 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.
PubMed 16741929Osman 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.
PubMed 27084787Troisi 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.
PubMed 12942477Yamada 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.
PubMed 18261170Umeda 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.
PubMed 18791439
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04252794
- Acronym / sponsor ID
- ILBS-Liver Transplant-02
- Conditions
- Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Due to shortage of deceased donor organs, LDLT (living donor living transplantation) is gaining importance all over world. Previous studies have showed poor outcomes with donor grafts having GRWR (graft to recipient weight ratio) < 0.8 due to development of SFSS (Small for Size Syndrome) where the graft is too small to meet the recipient's metabolic demands. SFSS is characterised by prolonged cholestasis, intractable ascites, prolonged INR and encephalopathy. However, it is not always possible to obtain larger graft from live donor owing to the risk's associated to donor. Various techniques have been developed in order to manage a smaller graft in recipient (ex: hemiportocaval shunts, splenic artery ligation, splenectomy). HPCS (hemiportocaval shunt) have been associated with risks of portal steal phenomenon and encephalopathy. Splenectomy is associated with increased risks of infections / sepsis and portal vein thrombosis postoperatively. Splenic artery ligation close to its origin is associated with least risks and is increasingly being used as the method of graft inflow modulation when required.
Recent studies have showed that Portal Flow Hemodynamics are more important than GRWR in predicting the occurrence of SFSS. Grafts whose GRWR is > 0.8 can also show features of SFSS after ruling out all other causes (5). Persistent portal hypertension leads to sinusoidal endothelial injury, haemorrhage, oedema and architectural distortion - these changes are more marked in SFS (small for size) grafts. Also, due to hepatic arterial buffer response, reduced flow in hepatic artery leads to further ischemic injury, cholestasis and ischemic cholangitis. A recipient portal venous flow of > 250 ml/min/100 grams of liver weight is defined as portal hyper perfusion.
H Y Ou et al retrospectively analysed data involving patients whose PVF > 250 ml/min/100 gr after reperfusion where 6 patients underwent inflow modulation (using splenic artery ligation) and other 2 didn't. They found that only 1 / 6 patients in those who underwent GIM developed SFSS where as both the patients who didn't undergo GIM developed SFSS (1 of them died). Also, none of the patients developed complications related to splenic artery ligation in their study.
Bhavin B et al in their retrospective study on 134 liver transplant recipients found that 19 patients met criteria for SFSS (as per Kyushu University). On analysis of the factors responsible for early graft dysfunction, only portal vein flow > 190 ml/min/100 gr of liver after reperfusion was found to be a significant predictor. GRWR was not significantly associated with graft dysfunction - 3 / 19 patients had GRWR < 0.8 while 16 patients in non-dysfunction group had GRWR < 0.8
Ogura et al retrospectively analysed data involving intentional portal pressure modulation when PVP (portal venous pressure) > 20 mm Hg. They found that the patients with a portal pressure < 15 mm Hg had better 2 year survival compared to those with > 15 mm Hg. Also, recovery from hyper bilirubinaemia and coagulopathy after transplantation was significantly better in those with PVP < 15 mm Hg.
Wang et al retrospectively analysed data involving 276 patients where they performed GIM by doing splenectomy (SPL) when PVP > 20 mm Hg. Group 1 had 134 patients who underwent SPL and Group 2 had 122 patients in whom GIM was not done. Graft compliance, Portal venous flow was significantly better in group 1 patients. Also, there was faster normalisation of bilirubin and ascites in group 1 when compared to group 2. Overall, 15.6 % patients had complications related to SPL - bleeding from splenic hilum, pancreatic leak, OPSS (overwhelming post spleenectomy sepsis) (1.9%).
Luca A et al in their study involving cirrhotic patients with portal hypertension, splenic artery occlusion causes a significant reduction in portal pressure gradient (PPG). This drop was indirectly related to liver volume and directly related to spleen volume. The spleen/liver volume ratio> 0.5 accurately predicts the drop in PPG and may be used to identify patients who can obtain a significant advantage from procedures decreasing splenic inflow.
Ayman et al had done a study wherethey aimed to keep final PVP < 20 mm Hg and analysed if PVP > 15 is a better predictor than PVP > 20 mm Hg for SFSS. Peak bilirubin, INR, incidence of post-transplant HE and SFSS was significantly higher in those with PVP of 15 - 19 mm Hg (group B) vs in those with PVP < 15 mm Hg (group A). 90 day morbidity and mortality was also significantly higher in Group B when compared to group A. On comparing grafts with GRWR < 0.8 with > 0.8, no significant differences in postoperative outcomes were seen.
Troisi et al did a retrospective study where they used Splenic artery ligation as the method of GIM when Recipient Portal Venous Flow was three times that of Donor portal vein flow. Group 1 had 11 patients with no GIM and group 2 had 13 patients who underwent GIM. SFSS occurred in three patients in Group 1 where all three needed re-transplantation whereas none of the patients in Group 2 developed SFSS. Also, One-year overallsurvival was 62% and 93% respectively for Group 1 and Group 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo GIM | Experimental | Procedure: Splenic artery ligationIf inclusion criteria are met, after randomisation, these group of patients will undergo splenic artery ligation (graft inflow modulation) |
| No splenic artery ligation | Active comparator | Other: No interventionIf inclusion criteria are met, after randomisation, these group of patients will not undergo splenic artery ligation (graft inflow modulation) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splenic artery ligationSplenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas | Procedure or surgery | Patients who undergo GIM |
| No interventionSplenic artery is not ligated despite the presence of portal hyperperfusion | Other | No splenic artery ligation |
Primary outcome
Incidence of early graft dysfunction
Time frame: first postoperative month
Number of patients who develop early graft dysfunction in each group
7 secondary outcomes
Time to normalisation of bilirubin
Time frame: first postoperative month
Time to normalisation of INR
Time frame: first postoperative month
Time to normalisation of ascites output
Time frame: first postoperative month
Morbidity
Time frame: first postoperative month
ICU stay
Time frame: first operative month
Mortality
Time frame: first postoperative month
Total hospital stay
Time frame: till 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Results publication: PubMed 10075602Kiuchi 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.
- Results publication: PubMed 29752783Bell 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.
- Results publication: PubMed 24370677Vasavada 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.
- Results publication: PubMed 25299370Vasavada 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.
- Results publication: PubMed 22260833Lei 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.
- Results publication: PubMed 16861970Demetris 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.
- Results publication: PubMed 11267312Shimamura 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.
- Results publication: PubMed 20430194Ou 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.
- Results publication: PubMed 20517905Ogura 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.
- Results publication: PubMed 25080864Wang 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.
- Results publication: PubMed 16741929Luca 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.
- Results publication: PubMed 27084787Osman 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.
- Hemodynamic interaction between portal vien and hepatic artery flow in small-for-size split liver transplantation - Smyrniotis - 2002 - Transplant International - Wiley Online LibraryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gattu Tharun, MS principal investigator
Senior resident, Department of HPB surgery, ILBS, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splenic artery ligation in people with Cirrhosis, Liver, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early graft dysfunction (time frame: first postoperative month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252794, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.