Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

Hepatolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297099
• Other study ID #: SWHZSG006
• Secondary ID: Zhengshuguo
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2018
• Source: Southwest Hospital, China
• Contact: Shuguo Zheng
• Phone: 0086-13508308676
• Email: shuguozh[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatolithiasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative complications	ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.	Duration hospitalization(an expected average of 7 days)
Primary	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	intraoperative parameters	operation time, intraoperative blood loss, rate of blood transfusion	during the operation