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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707810
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Paulo Celso Bosco Massarollo, University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Paulo Celso Bosco Massarollo, University of Sao Paulo:

Primary Outcome Measures:
  • Hepatic vein and right atrium pressure measurements (observed FHPV-CVP gradient values) [ Time Frame: intraoperatory ]
    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 ]
    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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 12, 2012
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Paulo Celso Bosco Massarollo, University of Sao Paulo:
Liver transplatation

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