Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

NCT03297099 | Unknown DMC

• 2 other identifiers: SWHZSG006Zhengshuguo
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatolithiasis

Keywords

robot-assisted laparosocpic; hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• intraoperative parameters

  during the operation

Other Outcomes (1)

• postoperative complications

  Duration hospitalization(an expected average of 7 days)

Study Arms (2)

Robot-assisted Laparoscopic operation

EXPERIMENTAL

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

Open surgery

ACTIVE COMPARATOR

The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis.

Procedure: open surgery

Interventions

Robot-assisted Laparoscopic operation PROCEDURE

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.

Robot-assisted Laparoscopic operation

open surgery PROCEDURE

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.

Open surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intrahepatic bile duct stones or hepatolithiasis.
• 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
• Age: Between 18 to 70 years
• Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
• Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved

You may not qualify if:

• Written informed consent
• Patients with bad general condition or important organ lesions, liver resection could not be tolerated
• Age:Younger than 18 or more than 70 years old
• Malignant tumor recurrence within one month postoperation
• Complicated case need to get emergency operation
• 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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shuguo Zheng

  Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Shuguo Zheng

CONTACT

0086-13508308676; shuguozh@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 29, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CN (1)