Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits

Recurrence of HCC After LDLT Clinical Trial

Official title:

Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937286
• Other study ID #: Hepatocellular carcinaoma
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: September 4, 2013
• Start date: January 2002
• Est. completion date: April 2012

Study information

• Verified date: September 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Health,organ transplantation committee,Egypt':'
• Study type: Observational

Clinical Trial Summary

Within community with high incidence of HCC, stretching the limits could be justified based on tumor characters and its biological behavior

Description:

590 Egyptian patients underwent LDLT; of them, 172 (32%) patients were transplanted for HCC. Twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to non HCC related mortality (n=4). One hundred forty six patients were retrospectively reviewed to determine prognostic factors for recurrence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

• Egyptien Patients with HCC

• Patients within Milan Criteria

• Patients beyond Milan criteria are selected on a case by case basis until 2005. From 2005 , patients beyond Milan criteria are subjected to down staging protocol and then reassessed (pre transplantation local ablative therapy either with RFA or TACE according to the size and the site of the lesion and we wait for 12 weeks after ablation ,only those with well ablated lesions, decreased AFP and no denovo lesions were transplanted).

Exclusion Criteria:

• • Evidence of macro vascular invasion by CT portography and/or US duplex.

• Metastatic HCC

• General contraindications for LT (ongoing sepsis, other major co morbidities,…).

• Early postoperative mortality (first1 month).

• Post transplant mortality during the period of follow up due to any cause other than recurrent HCC (e.g. sepsis, rejection, cardiological or cerebrovascular complications…)

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Recurrence
• Recurrence of HCC After LDLT

Locations

Country	Name	City	State
Egypt	Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university	Cairo,

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Hepatocellular carcinoma after LDLT		at least 6 months	Yes