Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

A Prospective Cohort Study: Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis. Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible. The study aimed to evaluate the safety, feasibility, and efficacy of robot assist laparoscopic surgery for the treatment of complicated hepatolithiasis by contrast of open procedures.

Study Overview

• Status: Unknown
• Conditions: Hepatolithiasis
• Intervention / Treatment: Procedure: Robot-assisted Laparoscopic operation; Procedure: open surgery

Detailed Description

Robot-assisted laparoscopic operation is a safe and feasible treatment for selected patients with complicated hepatolithiasis, with an advantage over open surgery in the field of intraoperative blood loss, less hilar occlusion, lower transfusion rate, less postoperative hospital stay.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital
      • Contact: Shuguo Zheng, Professor; Phone Number: 0086-13508308676; Email: shuguozh@yahoo.com.cn
      • Principal Investigator: Shuguo Zheng, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with intrahepatic bile duct stones or hepatolithiasis.
2. Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved
3. Age: Between 18 to 70 years
4. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
5. Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
6. Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria
7. Written informed consent

Exclusion Criteria:

1. Patients with bad general condition or important organ lesions, liver resection could not be tolerated
2. Age:Younger than 18 or more than 70 years old
3. Malignant tumor recurrence within one month postoperation
4. Complicated case need to get emergency operation
5. Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robot-assisted Laparoscopic operation; Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible.	Procedure: Robot-assisted Laparoscopic operation; Thirty patients with hepatolithiasis were selected and divided into robot group as described in the detailed description. Under general anesthesia, the patient was placed in a supine 30-degree reverse Trendelengburg position with both legs separating. The surgeon work on the console, and assist surgeon stand between legs. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.
ACTIVE_COMPARATOR: Open surgery; The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis.	Procedure: open surgery; surgery group as described in the detailed description.Open surgery was performed under general anesthesia with the patient in the supine position. Routinely, a reversed L-shape incision was performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
initial stone clearance rate	rate of the removal of the stones from intrahepatic bile duct identified by ultrasonic or computed tomography or magnetic resonance	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative parameters	operation time, intraoperative blood loss, rate of blood transfusion	during the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.	Duration hospitalization(an expected average of 7 days)

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (ACTUAL): September 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: hepatectomy; robot-assisted laparosocpic
• Other Study ID Numbers: SWHZSG006; zhengshuguo (Registry Identifier: zhengshuguo)

Drug and device information, study documents

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