Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis

Cholelithiasis Clinical Trial

Official title:

The Study of Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02127242
• Other study ID #: Fanyingfang2
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: April 29, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2014
• Source: Zhujiang Hospital
• Contact: Wang Li qing, Doctor
• Phone: +86-02062783391
• Email: wliqing07[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objective:the purpose of this study is to investigate the efficacy,feasibility,reliability,and safety of laparoscope combined air-pressure ballistic lithotripsy in the treatment of patients with bile duct stones.

Methods:We are going to select 60 patients diagnosed with hepatolithiasis who carry on the treatment in our hospital from April 2014 to April 2015.According to the unified inclusion and exclusion criteria,the patients are divided into the experimental group and the control group.The experimental group use the treatment of laparoscope combine with air-pressure ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients with hepatolithiasis with the method of lobectomy and segmental resection of liver.Contrastive analyzed two group of patients' clinical care effects.

Research hypothesis:according to compare two groups' duration of surgery,blood loss,postoperative complication rate,hospital stay,the stone clearance rate,,the residual stone rate,reoperation rate etc.We suppose that the clinical results of the experimental group are superior to the control group,difference is statistically significant(P<0.05).So we can draw the conclusion that the method of laparoscope combined air-pressure ballistic lithotripsy is useful in treatment of patients with hepatolithiasis.

Description:

To select 60 patients diagnosed with hepatolithiasis who carry on the treatment in our hospital from April 2014 to April 2015.According to the unified inclusion and exclusion criteria,the patients are divided into the experimental group and the control group.The experimental group use the treatment of laparoscope combine with air-pressure ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients with hepatolithiasis with the method of lobectomy and segmental resection of liver.

The experimental group performed under the situation of tracheal intubation general,placing the ureteroscope into common bile duct and exploring the bile duct after laparoscopic cholecystectomy and choledochotomy.Associated with air-pressure ballistic lithotripsy once discover bile duct stones and retrieve the rubble by flowing it out.To stone's diameter lower than 5 mm,use lithotomy forceps pull it out.Examining the bottom of common bile duct,ensuring that it will not obstructed.Last,placing the T-tube continuous drainage the residual stones.The control group using the way of hepatectomy.Choosing suitable surgical options according to the stones' location and associating with choledochoenterostomy if needed.

Contrastive analyse two groups' clinical indicators,such as operation time,blood loss during the surgery,hospital stay,the stone clearance rate,the residual stone rate,the incidence of postoperative complications and so on.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with hepatolithiasis;

• Patients with hepatolithiasis and extrahepatic bile duct stones or gallbladder stones;

• Patients with hepatolithiasis and acute cholangitis whose inflammation subside more than one month by conservative therapy.

• Regularly visiting our hospital;

• Willing to comply with all study procedures and provided signed and dated informed consent.

Exclusion Criteria:

• Simply gallbladder stones;

• Hepatolithiasis with carol's disease;

• Hepatolithiasis with bile duct carcinoma;

• patients with the clinical performances of severe cholangitis;

• patients with biliary stricture obviously;

• patients with heart,lungs,hepatic or renal dysfunction.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• ureteroscopic air-pressure ballistic lithotripsy
In case of large, hard or impacted stones ureteroscopic air-pressure ballistic lithotripter is used for fragmentation. The probe of the lithotripter target towards the stone and then fragmented.

Locations

Country	Name	City	State
China	Department of Hepatobiliary (I),Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Farooq Qadri SJ, Khan M, Khan N. Use of pneumatic lithotripsy for managing difficult CBD calculi. Int J Surg. 2011;9(1):59-62. doi: 10.1016/j.ijsu.2010.08.009. Epub 2010 Sep 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	reoperation rate		one month	No
Primary	residual stone rate		2 weeks	No
Primary	the stone clearance rate		2 weeks	No
Secondary	the incidence of postoperative complications		one month	Yes