Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03765645 |
| Other study ID # |
ILBS Liver Transplant 001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 4, 2018 |
| Est. completion date |
August 31, 2020 |
Study information
| Verified date |
February 2020 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious
use of antibiotics is therefore of extreme importance not just in preventing antibiotic
resistance but also it decreases cost of the treatment and prevent side-effects of the
antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in
patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual
institutional protocol. There have been studies, comparing short course vs long dose of
antibiotics in hepatectomy patients, concluding equivalent efficacy in preventing infective
complications. The investigators aim at proving that 3 doses of antibiotics are equally
effective in preventing infective complications, when compared to 9 doses of antibiotics, in
patients undergoing donor hepatectomy. So, a randomized trial is required to study the
antibiotic duration in patient undergoing donor hepatectomy.
Description:
Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious
use of antibiotics is therefore of extreme importance not just in preventing antibiotic
resistance but also it decreases cost of the treatment and prevent side-effects of the
antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in
patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual
institutional protocol. So, a randomized trial is required to study the antibiotic duration
in patient undergoing donor hepatectomy.
The investigators aim to prove that, in preventing infective complications, 3 doses of
antibiotics are equally effective as compared to 9 doses of antibiotics in patients of donor
hepatectomy.
Methodology:
The present study will be an equivalence randomized control trial where data will be
collected from patients who are undergoing donor hepatectomy. Donor evaluation will be done
according to institutional protocol. Donor evaluation will be done step wise as tabulated
below.
Surgical technique After opening the abdomen through a J-shaped incision, cholecystectomy
will be performed and intraoperative cholangiogram will be carried out through the cystic
duct stump. The ipsilateral lobe will be mobilized and the hepatic vein will be looped. Hilar
dissection will be performed and the ipsilateral portal vein and hepatic artery are defined.
The transection plane will be determined by the line of demarcation obtained by temporary
clamping of the ipsilateral portal vein and hepatic artery. Parenchymal transection will be
performed without inflow occlusion by a Cavitron Ultrasonic Surgical Aspirator (CUSA_;
Valleylab, Boulder, CO, USA). The last one-third of the transaction will be performed with a
hanging maneuver. After completion of the transaction, the bile duct will be looped along
with the sheath and a repeat cholangiogram will be performed by placing radio opaque markers
at the proposed bile duct transection site. The bile duct will be divided between the
markers. Intravenous heparin will be given (50 IU/kg); after waiting for 3 min, the hepatic
artery, portal vein and hepatic vein will be divided between clamps and the graft will be
taken out.
Assumptions:
- Prevalence of infective complications with 3 doses of antibiotic: 9%
- Prevalence of infective complications with 9 doses of antibiotic: 7% The alpha error,
the power of the study and the equivalence margin will be taken as 5%, 80% and 15%
respectively. For this investigators will need to enroll a total of 108 patients,
equally divided into 2 groups.
Group A shall include 54 consecutive patients who are undergoing donor hepatectomy. These
patients will be followed up closely in the post-operative period and would be serially
sampled at pre-defined intervals. Patients will be assessed for infective complications.
Antibiotics will be continued beyond 3 doses, if any sign of infection is present (Fever/ TLC
more than 11,000/ Wound infection/others).
Group B shall include 54 patients, who will receive antibiotics for 3 days. These patients
will also be followed up closely in the post-operative period and would be serially sampled
at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics
will be continued beyond 3 days, if any sign of infection is present (Fever/ TLC more than
11,000/ Wound infection/others).
Infective complication rates / total duration of antibiotics/ cost of antibiotics and
morbidity will be compared between the 2 cohorts.
EXPECTED OUTCOME: To establish that 3 doses of antibiotics are equally effective in
preventing infective complications, as compared to 9 doses of antibiotics, in patients
undergoing donor hepatectomy.
