Clinical trial NCT03672357: Short and Long Outcomes Between Laparoscopic and Open Hepatectomy
Official title: Short and Long Outcomes Between Laparoscopic and Open Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Liver Resection
Open Liver Resection
Keywords: Liver resection
Laparoscopic surgery
fast recovery
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of serum glutamic oxalacetic transaminase
timeFrame: up to 7 days after liver resection
measure: Change of serum glutamic-pyruvic transaminase
timeFrame: up to 7 days after liver resection
Secondary outcomes:
measure: Postoperative complication(Rates in different grades)
timeFrame: up to 30 days after liver resection
measure: Mortality rates
timeFrame: up to 30 days after liver resection
measure: Hospital duration after operation (days)
timeFrame: up to 30 days after liver resection
measure: Operation time(min)
timeFrame: up to 30 days after liver resection
measure: Blood loss(ml)
timeFrame: up to 30 days after liver resection
measure: Blood transfusion (times and units)
timeFrame: intraoperative
measure: Duration of nasogastric tubes (hours)
timeFrame: up to 14 days after liver resection7
measure: Duration of abdominal drain (days)
timeFrame: up to 14 days after liver resection
measure: Duration to first flatus (days)
timeFrame: up to 14 days after liver resection
measure: Comfort questionnaire measures (GCQ) measures by Kolcaba
timeFrame: up to 7 days after liver resection
measure: Resection margin status
timeFrame: up to 30 days after liver resection
measure: Intensive care unit stay (days)
timeFrame: up to 7 days after liver resection
measure: Readmission rate
timeFrame: up to 30 days after liver resection
measure: C-reactive protein (mg/mL)
timeFrame: up to 5 days after liver resection
measure: Disease recurrence rates
timeFrame: up to 5 years
measure: Overall survival time (month)
timeFrame: up to 5 years after operation
measure: Disease free survival time (month)
timeFrame: up to 5 years after operation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The second hospital of Anhui Medical University,
state: Anhui
Study officials:
References: