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The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.
All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purge | Experimental | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. |
|
| No Purge | No Intervention | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purge | Procedure | In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure | The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping | 5 minutes post-reperfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Biliary Complications (Participants) | Participants who developed biliary complications in three months period (Participant) | 3 months |
| Ischemia Reperfusion Injury | incidence of ischemia reperfusion injury in the transplanted graft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr M Yassen, MD | Mansoura Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver transplantation project - Gastroenterology surgical center - Mansoura university | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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Candidates recruited from patients admitted for living donor liver transplantation in Mansoura liver transplantation unit
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| ID | Title | Description |
|---|---|---|
| FG000 | Purge | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping |
| FG001 | No Purge | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Purge | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure | The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping | Posted | Mean | Standard Deviation | mmHg | 5 minutes post-reperfusion |
|
3 months complications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Purge | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 3 Months Mortality | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 30 days morbidity | Surgical and medical procedures | Systematic Assessment | NonLife threatening complications including infection, acute cellular rejection, vascular complications, biliary complications and IR injury |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amr Mohamed Yassen Ali Badawy | Mansoura Faculty of Medicine | +201001497044 | amryassen@hotmail.com |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| 7 days |
| Post-operative Infectious Complications | 30 days |
| 3 Months Mortality | mortality within first 3 post-operative months | 3 Months |
| BG001 | No Purge | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Purge | Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. |
|
|
| Secondary | Biliary Complications (Participants) | Participants who developed biliary complications in three months period (Participant) | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Ischemia Reperfusion Injury | incidence of ischemia reperfusion injury in the transplanted graft | Posted | Number | participants | 7 days |
|
|
|
| Secondary | Post-operative Infectious Complications | Posted | Number | participants | 30 days |
|
|
|
| Secondary | 3 Months Mortality | mortality within first 3 post-operative months | Posted | Number | participants | 3 Months |
|
|
|
| 4 |
| 40 |
| 18 |
| 40 |
| EG001 | No Purge | The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. | 3 | 40 | 15 | 40 |
|
| Infectious complications (30 days) | Infections and infestations | Systematic Assessment | Early infectious complications |
|
| Acute cellular rejection (30 Days) | Immune system disorders | Systematic Assessment |
|
| Ischemia/Reperfusion Injury (30 days) | General disorders | Systematic Assessment |
|
| Billiary complications (30 Days) | Hepatobiliary disorders | Systematic Assessment |
|
| Vascular complications (30 Days) | Vascular disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |