The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy
Keywords
Abstract
Description
Liver transplantation(LT) is the gold standard treatment for patients with end-stage liver disease. In light of advancements in surgical techniques, immunosuppressive agents, and perioperative critical care, the overall 3-year survival of patients undergoing LT has exceeded 80%. Despite its outstanding success, LT still entails certain complications including ischemia-reperfusion injury (IRI).
IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.
Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.
Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.
Dates
| Last Verified: | 07/31/2019 |
| First Submitted: | 12/14/2017 |
| Estimated Enrollment Submitted: | 12/20/2017 |
| First Posted: | 12/28/2017 |
| Last Update Submitted: | 08/09/2019 |
| Last Update Posted: | 08/18/2019 |
| Date of first submitted results: | 03/04/2019 |
| Date of first submitted QC results: | 08/09/2019 |
| Date of first posted results: | 08/18/2019 |
| Actual Study Start Date: | 08/21/2016 |
| Estimated Primary Completion Date: | 08/30/2017 |
| Estimated Study Completion Date: | 10/29/2017 |
Condition or disease
Intervention/treatment
Procedure: RIPC
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: RIPC intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. | Procedure: RIPC Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated |
| No Intervention: Control In the control group, the same maneuver was applied but without cuff inflation. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Donors who plan to have living right hepatectomy for liver transplantation. - age : between 18 to 60 years. Exclusion Criteria: - donors who plan to donate left lobe - donors who plan to have laparoscopic right hepatectomy - donors who cannot proceed remote ischemic preconditioning |
Outcome
Primary Outcome Measures
1. Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days [within 7 days after operation]
2. The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days [within 7 days after operation]
Secondary Outcome Measures
1. Number of Participants With Delayed Recovery of Liver Function [postoperative 7 days]
2. Postoperative Liver Regeneration [1 month]
