Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

NCT ID: NCT03297099

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-06-01

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.

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.

Conditions

Hepatolithiasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Robot-assisted Laparoscopic operation

Intervention Type: 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.

Open surgery

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

Group Type: ACTIVE_COMPARATOR

open surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

Exclusion Criteria

7. Written informed consent

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Shuguo Zheng, MD

Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuguo Zheng

Role: STUDY_DIRECTOR

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

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuguo Zheng

Role: CONTACT

shuguozh@yahoo.com.cn

0086-13508308676

Facility Contacts

Shuguo Zheng, Professor

Role: primary

shuguozh@yahoo.com.cn

0086-13508308676

Other Identifiers

Zhengshuguo

Identifier Type: REGISTRY

Identifier Source: secondary_id

SWHZSG006

Identifier Type: -

Identifier Source: org_study_id