Prospective Trial Comparing Conventional Versus Piggyback Method in Venous Drainage of the Transplanted Liver

NCT01707810 | Completed

• 1 other identifier: LIVER TRANSPLANT OUTFLOW
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

End-stage Liver Disease

Keywords

Liver transplatation

Outcome Measures

Primary Outcomes (1)

• Hepatic vein and right atrium pressure measurements (observed FHPV-CVP gradient values)

  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.

  intraoperatory

Secondary Outcomes (1)

• Serum Creatinine

  postoperative days (PO) 1 to 7 and on 14, 21 and 28

Study Arms (2)

Conventional method

SHAM COMPARATOR

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

Piggyback method

EXPERIMENTAL

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

Interventions

Piggyback method PROCEDURE

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.

Also known as: Liver transplantaton piggyback method

Piggyback method

conventional method PROCEDURE

Conventional method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (1)

• Brescia MD, Massarollo PC, Imakuma ES, Mies S. Prospective Randomized Trial Comparing Hepatic Venous Outflow and Renal Function after Conventional versus Piggyback Liver Transplantation. PLoS One. 2015 Jun 26;10(6):e0129923. doi: 10.1371/journal.pone.0129923. eCollection 2015.

  PMID: 26115520 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Paulo CB Massarollo, PhD

  Faculdade de Medicina da Universidade de São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 1999
• Primary Completion: September 1, 2000
• Study Completion: October 1, 2000
• Last Updated: October 16, 2012

Record last verified: 2012-10