Prospective Trial Comparing Conventional Versus Piggyback Method in Venous Drainage of the Transplanted Liver (LTx-outflow)

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Paulo Celso Bosco Massarollo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01707810
First received: October 12, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

METHODS: Patients were submitted to conventional (n=15) or piggyback (n=17) liver transplantation (LTx). Free hepatic vein pressure (FHVP) and the central venous pressure (CVP) measurements were performed after graft reperfusion. Postoperative (PO) serum creatinine (Cr) was measured, acute renal failure (ARF) was defined as Cr > or = 2,0mg/dL and PO renal function was analyzed by modificated RIFLE-AKIN. PO overall Cr was calculated by area under the curve (AUC) of Cr vs. time. on the first week.


Condition Intervention
End-stage Liver Disease
Procedure: Piggyback method
Procedure: conventional method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing the Clinical Efficiency of Conventional Versus Piggyback Method in Venous Drainage of the Transplanted Liver

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Hepatic vein and right atrium pressure measurements (observed FHPV-CVP gradient values) [ Time Frame: intraoperatory ] [ Designated as safety issue: No ]
    Free hepatic vein pressure (FHVP) was measured using an 8F polyethylene catheter with a multiperforated distal end, which was positioned in the graft's right hepatic vein during ex situ preparation on the back table. The proximal end of this catheter was exteriorized in the infrahepatic portion of IVC. In the conventional group, exteriorization was performed through the anastomosis suture. In the piggyback group, IVC was ligated around the catheter. Central venous pressure (CVP) was obtained using a Swan-Ganz catheter (routine procedure). Measurement of hepatic vein and right atrium pressure was made once, after concluding biliary anastomosis.


Secondary Outcome Measures:
  • Serum Creatinine [ Time Frame: postoperative days (PO) 1 to 7 and on 14, 21 and 28 ] [ Designated as safety issue: No ]
    Serum creatinine (Cr) was determined in the preoperatory period (immediately before surgery), on postoperative days (PO) 1 to 7 and on 14, 21 and 28. Occurrence of acute renal failure (ARF) was defined as postoperative creatinine peak > or = 2.0


Enrollment: 32
Study Start Date: October 1999
Study Completion Date: October 2000
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Conventional method
In the conventional method IVC was clamped during the anhepatic phase and venous return was maintained by a portal femoral axillary venovenous bypass with a centrifugal pump. In these cases, IVC reconstruction was performed by end-to-end anastomosis above and below the liver.
Procedure: conventional method
Experimental: Piggyback method
In the piggyback method IVC was not clamped in any case. Implantation method of the grafted IVC in recipient IVC was not standardized, being defined by the responsible surgeon during the procedure. In the two groups, all patients were submitted to simultaneous arterial and portal revascularization, according to the routine of the service.
Procedure: Piggyback method
In the piggyback method IVC was not clamped in any case. Implantation method of the grafted IVC in recipient IVC was not standardized, being defined by the responsible surgeon during the procedure. In the two groups, all patients were submitted to simultaneous arterial and portal revascularization, according to the routine of the service.
Other Name: Liver transplantaton piggyback method

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria admitted of both genders, aged 18 years or older, submitted to a first elective LTx, with no clinical or technical reasons justifying a preferential option by conventional or piggyback method

Exclusion Criteria:

  • patients submitted to living donor LTx, in whom IVC is routinely preserved and those with familial amyloidotic polyneuropathy, whom, in our routine, are routinely submitted to conventional LTx.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01707810

Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Paulo CB Massarollo, PhD Faculdade de Medicina da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: Paulo Celso Bosco Massarollo, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01707810     History of Changes
Other Study ID Numbers: LIVER TRANSPLANT OUTFLOW
Study First Received: October 12, 2012
Last Updated: October 15, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Liver transplatation

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on August 21, 2014