Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2024

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

  • Procedure: Laparoscopic liver resection
    • Laparoscopic hepatectomy
  • Procedure: Open liver resection
    • Traditional open hepatectomy

Arms, Groups and Cohorts

  • Experimental: Laparoscopic liver resection
    • Laparoscopic hepatectomy
  • Other: Open liver resection
    • Open hepatectomy

Clinical Trial Outcome Measures

Primary Measures

  • Change of serum glutamic oxalacetic transaminase
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Postoperative complication(Rates in different grades)
    • Time Frame: up to 30 days after liver resection
    • According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/
  • Mortality rates
    • Time Frame: up to 30 days after liver resection
    • the rate of postoperative death
  • Hospital duration after operation (days)
    • Time Frame: up to 30 days after liver resection
    • the length of hospital stay
  • Operation time(min)
    • Time Frame: up to 30 days after liver resection
    • the during of operation
  • Blood loss(ml)
    • Time Frame: up to 30 days after liver resection
    • the volume of blood loss
  • Blood transfusion (times and units)
    • Time Frame: intraoperative
    • intraoperative blood transfusion
  • Duration of nasogastric tubes (hours)
    • Time Frame: up to 14 days after liver resection7
    • Duration of nasogastric tubes
  • Duration of abdominal drain (days)
    • Time Frame: up to 14 days after liver resection
    • Duration of abdominal drain
  • Duration to first flatus (days)
    • Time Frame: up to 14 days after liver resection
    • Duration to first flatus
  • Comfort questionnaire measures (GCQ) measures by Kolcaba
    • Time Frame: up to 7 days after liver resection
    • GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html.
  • Resection margin status
    • Time Frame: up to 30 days after liver resection
    • the R0 resection rate
  • Intensive care unit stay (days)
    • Time Frame: up to 7 days after liver resection
    • Intensive care unit stay in days
  • Readmission rate
    • Time Frame: up to 30 days after liver resection
    • measure the rate of readmission
  • C-reactive protein (mg/mL)
    • Time Frame: up to 5 days after liver resection
    • C-reactive protein levels on preoperative and postoperative day-1,3,5
  • Disease recurrence rates
    • Time Frame: up to 5 years
    • The disease recurrence after operation
  • Overall survival time (month)
    • Time Frame: up to 5 years after operation
    • Overall survival time after operation
  • Disease free survival time (month)
    • Time Frame: up to 5 years after operation
    • Disease free survival time after operation

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • hui hou
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: hui hou, Director of the hepatobiliary surgery department – The Second Hospital of Anhui Medical University
  • Overall Contact(s)
    • dachen zhou, MD, +8618160885015, zdc1987@yeah.net

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