A clinical trial to compare the outcomes between two different liver grafts in recipients and donors after live donor liver transplantation

Active, not recruiting

Conditions: To study the early post operative outcomes in patients who undergoe live donor liver transplantation as per standard accepted criteria.Outcome in donors who undergoe the donor surgery is also studied

Registration Number: CTRI/2016/08/007186

Lead Sponsor: Christi Titus Varghese

Brief Summary: This is a randomized parallel group trial designed to assess the early post operative outcomes in donors and recipients who undergoe Live donor liver transplantation.Outcomes in extended graft[with native middle hepatic vein] is compared with modified graft[with neo middle hepatic vein].It is conducted at a single centre [Amrita instititue of Medical sciences,Kochi,Kerala].Primary outcomes assessed in the recipient are Early allograft dysfunctio,.Primary graft non function,Small for size syndrome,Number of days in ICU and mortality at the end of 90 days.Primary outcomes assessed in the donor are Post hepatectomy liver failure,Volume regeneration after 60 days,Clavien Dindo Grading of post surgery morbidity and number of days in ICU after surgery.Change in post surgery liver parameters are also analysed in donor and recipient.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 61

Inclusion Criteria

.Patients with liver disease who meet the criteria for live donor liver transplantation .Live donor suitable for extended right hepatectomy[with middle hepatic vein] a.Has a future liver remnant of more than 30% b.Live donor with adequate segment 4a drainage to left hepatic vein[usually a umblical vein] c.Steatosis less than 20% as assessed by L-S ratio on plain CT.

Exclusion Criteria

.Thrombosed recipient portal Vein.
.Graft to recipient wight ratio less than 0.7. .Venous drainage of segment 4 mainly to middle hepatic vein in donor .ABO incompatible liver transplants .Donor at or above 55 years of age.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post Hepatectomy liver failure[PHLF}	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Post operative Clavien-Dindo score	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Number of days in hospital after surgery	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Recipient:	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Early Allograft Dysfuction[EAD]	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Small for size Syndrome[SFSS]	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Primary graft non function[PGNF}	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Patency of Middle hepatic vein	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Number of days in ICU	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Mortality at the end of 90 days	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Donor:	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
CT based volume regeneration at the end of 60 days	All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.

Secondary Outcome Measures

Name	Time	Method
Change in post surgery liver parameters in donor and recipient	Untill discharge/ 1Month [whichever comes later]

Trial Locations

Locations (1): Amrita Institute Of Medical Sciences
🇮🇳
Ernakulam, KERALA, India
Amrita Institute Of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Dr Christi Titus Varghese
Principal investigator
9447798658
christititus@gmail.com