Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Device: 5mm spring clip

• Registration Number: NCT00527644
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative day one to check for biliary leaks.

Detailed Description

The purpose of this study is to evaluate how effective the Visu-Lock clip is at preventing leakage of bile (liquid made by liver and stored in gall bladder) after gallbladder surgery. It is not known if the Visu-Lock clip stops leaks better than other clips that have been used during gallbladder surgery.

Null hypothesis: There is no difference in subclinical or clinical leak rate between spring and crush clips used for cystic duct ligation.

Alternative hypothesis: Titanium spring clips decrease the rate of subclinical or clinical biliary leak from the cystic duct stump after laparoscopic cholecystectomy.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2017-10-24
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-28
• Results First Posted: 2017-12-06
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Adult(18 or older)
• Diagnosis of cholelithiasis or cholecystitis
• Diagnosis of choledocholithiasis or biliary dyskinesia
• scheduled fo laparoscopic cholecystectomy
• Females: NOT pregnant

Exclusion Criteria

• Breastfeeding
• Malignancy
• Inflammatory bowel disease (IBD)
• Ulcerative colitis (UC)
• Receiving steroids
• Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
• History of connective tissue disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spring Clips	5mm spring clip	Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.

Primary Outcome Measures

Name	Time	Method
No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.	By post op day one HIDA scan.

Secondary Outcome Measures

Name	Time	Method
Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.	By post op day one HIDA scan.

Trial Locations

Locations (1)

University of Missouri Hospital and Clinics; 🇺🇸 Columbia, Missouri, United States