Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

hui hou

Status: Not yet enrolling

Conditions: Laparoscopic Liver Resection; Open Liver Resection

Treatments: Procedure: Open liver resection; Procedure: Laparoscopic liver resection

Study type: Interventional

Funder types: Other

Identifiers

NCT03672357

LLR_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Laparoscopic liver resection

Experimental group

Description:

Laparoscopic hepatectomy

Treatment:

Procedure: Laparoscopic liver resection

Open liver resection

Other group

Description:

Open hepatectomy

Treatment:

Procedure: Open liver resection