Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

Army Medical University

Status: Unknown

Conditions: Hepatolithiasis

Treatments: Procedure: open surgery; Procedure: Robot-assisted Laparoscopic operation

Study type: Interventional

Funder types: Other

Identifiers

NCT03297099

Zhengshuguo (Registry Identifier)

SWHZSG006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Robot-assisted Laparoscopic operation

Experimental group

Description:

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.

Treatment:

Procedure: Robot-assisted Laparoscopic operation

Open surgery

Active Comparator group

Description:

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

Treatment:

Procedure: open surgery