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

Primary Purpose

Cholelithiasis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ureteroscopic air-pressure ballistic lithotripsy
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring hepatolithiasis, ureteroscope, air-pressure ballistic lithotripsy, hepatectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Hepatobiliary (I),Zhujiang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

air-pressure ballistic lithotripsy

hepatectomy group

Arm Description

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.

Hepatic resection using an open approach is performed for all segments affected by biliary stenosis and the affected bile duct drainage area.Hepaticojejunostomy is performed in patients with common bile duct stenosis and in those considered to be at high risk for recurrence.

Outcomes

Primary Outcome Measures

residual stone rate
the stone clearance rate

Secondary Outcome Measures

the incidence of postoperative complications

Full Information

First Posted
April 28, 2014
Last Updated
April 29, 2014
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02127242
Brief Title
Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis
Official Title
The Study of Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
hepatolithiasis, ureteroscope, air-pressure ballistic lithotripsy, hepatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
air-pressure ballistic lithotripsy
Arm Type
Experimental
Arm Description
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.
Arm Title
hepatectomy group
Arm Type
No Intervention
Arm Description
Hepatic resection using an open approach is performed for all segments affected by biliary stenosis and the affected bile duct drainage area.Hepaticojejunostomy is performed in patients with common bile duct stenosis and in those considered to be at high risk for recurrence.
Intervention Type
Procedure
Intervention Name(s)
ureteroscopic air-pressure ballistic lithotripsy
Other Intervention Name(s)
UAPBL
Intervention Description
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.
Primary Outcome Measure Information:
Title
residual stone rate
Time Frame
2 weeks
Title
the stone clearance rate
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
the incidence of postoperative complications
Time Frame
one month
Other Pre-specified Outcome Measures:
Title
reoperation rate
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Li qing, Doctor
Phone
+86-02062783391
Email
wliqing07@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan y fang, Prof.
Organizational Affiliation
Department of Hepatobiliary Surgery(I),Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hepatobiliary (I),Zhujiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan y fang, Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
20849989
Citation
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.
Results Reference
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Laparoscope Combined Ureteroscopic Air-pressure Ballistic Lithotripsy to Treat Patients With Hepatolithiasis

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