NCT02127242

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

April 28, 2014

Last Update Submit

April 29, 2014

Conditions

Cholelithiasis

Keywords

hepatolithiasisureteroscopeair-pressure ballistic lithotripsyhepatectomy

Outcome Measures

Primary Outcomes (2)

  • residual stone rate

    2 weeks

  • the stone clearance rate

    2 weeks

Secondary Outcomes (1)

  • the incidence of postoperative complications

    one month

Other Outcomes (1)

  • reoperation rate

    one month

Study Arms (2)

air-pressure ballistic lithotripsy

EXPERIMENTAL

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.

Procedure: ureteroscopic air-pressure ballistic lithotripsy

hepatectomy group

NO INTERVENTION

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.

Interventions

ureteroscopic air-pressure ballistic lithotripsyPROCEDURE

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.

Also known as: UAPBL
air-pressure ballistic lithotripsy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobiliary (I),Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

Related 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.

    PMID: 20849989BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Fan y fang, Prof.

    Department of Hepatobiliary Surgery(I),Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Li qing, Doctor

CONTACT

+86-02062783391wliqing07@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

April 30, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

CN(1)