Laparoscopic Liver Resection, Open Liver Resection
Conditions
Keywords
Liver resection, Laparoscopic surgery, fast recovery
Brief summary
LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.
Detailed description
The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.
Interventions
PROCEDURELaparoscopic liver resection
Laparoscopic hepatectomy
PROCEDUREOpen liver resection
Traditional open hepatectomy
Sponsors
hui hou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection; 2. Child-Pugh A without portal hypertension 3. No portosystemic shunt 4. No previous abdominal operation history. 5. American society of anesthesiology class(ASA): I or II 6. Age 18 to 80
Exclusion criteria
1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others) 2. Combined hepatectomy 3. Intrahepatic duct stone disease 4. Liver disease caused splenomegaly 5. Previous hepatectomy 6. Combined operation for extrahepatic disease 7. Vulnerable population (mental retardation, pregnancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum glutamic oxalacetic transaminase | up to 7 days after liver resection | Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7. |
| Change of serum glutamic-pyruvic transaminase | up to 7 days after liver resection | Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital duration after operation (days) | up to 30 days after liver resection | the length of hospital stay |
| Operation time(min) | up to 30 days after liver resection | the during of operation |
| Blood loss(ml) | up to 30 days after liver resection | the volume of blood loss |
| Blood transfusion (times and units) | intraoperative | intraoperative blood transfusion |
| Duration of nasogastric tubes (hours) | up to 14 days after liver resection7 | Duration of nasogastric tubes |
| Duration of abdominal drain (days) | up to 14 days after liver resection | Duration of abdominal drain |
| Duration to first flatus (days) | up to 14 days after liver resection | Duration to first flatus |
| Postoperative complication(Rates in different grades) | up to 30 days after liver resection | According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/ |
| Resection margin status | up to 30 days after liver resection | the R0 resection rate |
| Intensive care unit stay (days) | up to 7 days after liver resection | Intensive care unit stay in days |
| Readmission rate | up to 30 days after liver resection | measure the rate of readmission |
| C-reactive protein (mg/mL) | up to 5 days after liver resection | C-reactive protein levels on preoperative and postoperative day-1,3,5 |
| Disease recurrence rates | up to 5 years | The disease recurrence after operation |
| Overall survival time (month) | up to 5 years after operation | Overall survival time after operation |
| Disease free survival time (month) | up to 5 years after operation | Disease free survival time after operation |
| Comfort questionnaire measures (GCQ) measures by Kolcaba | up to 7 days after liver resection | GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html. |
| Mortality rates | up to 30 days after liver resection | the rate of postoperative death |
Countries
China
Contacts
Primary Contactdachen zhou, MD
Outcome results
None listed