Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

Not Applicable

Not yet recruiting

• Conditions: Open Liver Resection; Laparoscopic Liver Resection
• Interventions: Procedure: Laparoscopic liver resection; Procedure: Open liver resection

• Registration Number: NCT03672357
• Lead Sponsor: hui hou

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.

Study Timeline

• Study First Submitted: 2018-08-19
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13
• Study Start: 2019-01-01
• Primary Completion: 2024-09-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic liver resection	Laparoscopic liver resection	Laparoscopic hepatectomy
Open liver resection	Open liver resection	Open hepatectomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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/
Mortality rates	up to 30 days after liver resection	the rate of postoperative death
Hospital duration after operation (days)	up to 30 days after liver resection	the length of hospital stay
Intensive care unit stay (days)	up to 7 days after liver resection	Intensive care unit stay in days
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 to first flatus (days)	up to 14 days after liver resection	Duration to first flatus
Resection margin status	up to 30 days after liver resection	the R0 resection rate
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
Duration of abdominal drain (days)	up to 14 days after liver resection	Duration of abdominal drain
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.
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

Trial Locations

Locations (1)

The second hospital of Anhui Medical University,; 🇨🇳 Hefei, Anhui, China