Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation: a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Incidence of early graft dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of early graft dysfunction
时间窗: first postoperative month
Number of patients who develop early graft dysfunction in each group
次要结局
- Mortality(first postoperative month)
- Time to normalisation of bilirubin(first postoperative month)
- ICU stay(first operative month)
- Time to normalisation of INR(first postoperative month)
- Time to normalisation of ascites output(first postoperative month)
- Morbidity(first postoperative month)
- Total hospital stay(till 3 months after surgery)
研究者
Gattu Tharun
Senior Resident, HPB Surgery
Institute of Liver and Biliary Sciences, India
