Open Versus Laparoscopic Left Hepatic Sectionectomy

Randomized Clinical Trial of Open Versus Laparoscopic Left Hepatic Sectionectomy in Treatment of Hepatolithiasis Within an Enhanced Recovery After Surgery Programme

Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Liver Resection; Enhanced Recovery; Hepatolithiasis; Open Liver Resection
• Intervention / Treatment: Procedure: open left hepatic sectionectomy; Procedure: laparoscopic hepatic sectionectomy

Detailed Description

The application of laparoscopic technology to liver surgery has been developing rapidly, yet very few studies have been conducted to compare the outcomes between open and laparoscopic liver resections. So little is known about their advantages and disadvantages. The aim of this prospective randomized study is to compare the outcomes between laparoscopic and open liver resection in treatment of hepatolithiasis within the left lobes within an enhanced recovery after surgery programme.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hui s hou, master; Phone Number: +8615856943673 +8615856943673; Email: aydpanshubo@126.com
• Study Contact Backup: Name: shubo s pan, Doctor; Phone Number: +8615856943673 +8615856943673; Email: aydpanshubo@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • Recruiting
      • The second hospital of Anhui Medical University,
      • Contact: shubo pan; Phone Number: +8615856943673 +8615856943673; Email: aydpanshubo@126.com
      • Contact: hui hou; Phone Number: +8615856943673 +8615856943673; Email: aydpanshubo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients suitable for undergoing both laparoscopic left sectionectomy as well as open left sectionectomy of the liver
• Able to understand the nature of the study and what will be required of them
• Men and non-pregnant,non-lactating women between age 18-80
• BMI between 18-35
• Patients with ASA I-II-III

Exclusion Criteria:

• Inability to give written informed consent
• Patients undergoing liver resection other than left lateral hepatic sectionectomy
• Patients with ASA IV-V Underlying liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: open left hepatic sectionectomy; patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme	Procedure: open left hepatic sectionectomy; patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme
Experimental: laparoscopic hepatic sectionectomy; patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme	Procedure: laparoscopic hepatic sectionectomy; patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme; Other Names: open left hepatic sectionectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital duration after operation (days)	the length of hospital stay	up to 30 days after liver resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission percentage	Readmission percentage during one year follow-up	up to 30 days after liver resection
Total morbidity	According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/	up to 1 year after liver resection
Composite endpoint of liver surgery specific morbidity	Parameter composed of a combination of procedure-specific complications and considered as a single, dichotomous outcome: operative mortality, intra-abdominal haemorrhage, ascites, bile leakage, intra-abdominal abscess and postresectional liver failure. These components, which are all specific to liver surgery and have substantial clinical relevance, reflect Dindo grade 3-5 complications. A composite score of 1 (=failure) will reflect the occurrence of at least one of the above liver specific complications, consequently a score of 0 (=success) will be assigned if none occur.	up to 1 year after liver resection
Hospital and societal costs	The economic evaluation will include a cost-utility analysis from a Dutch societal perspective. The incremental costs per Quality Adjusted Life Year (QALY) gained will be based on utility scores from the EQ-5D. All hospital expenses (direct and indirect) related to both interventions will be monitored. In addition, a cost questionnaire offered at the regular follow-up consultation (3, 6 and 12 months) will help us to assess the societal and individual costs outside health care relating to patients' absence, impaired mobility, work or normal daily activities.	up to 1 year after liver resection
Incidence of incisional hernias	To assess the incidence of incisional hernias in laparoscopic and open left lateral hepatic sectionectomy patients will be contacted at a mean time of 1 year after resection to receive an ultrasound to diagnose incisional hernia.	up to 1 year after liver resection
Change of serum glutamic oxalacetic transaminase	Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.	up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase	Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.	up to 7 days after liver resection
Mortality rates	the rate of postoperative death	up to 30 days after liver resection
Operation time(min)	the during of operation	intraoperative
Blood loss(ml)	the volume of blood loss	up to 30 days after liver resection
Blood transfusion (times and units)	intraoperative blood transfusion	intraoperative
C-reactive protein (mg/mL)	C-reactive protein levels on preoperative and postoperative day-1,3,5	up to 5 days after liver resection

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Investigators: Study Chair: hui hou, master, Second Affiliated hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2019
• Primary Completion (Anticipated): December 26, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No