Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Spring Clips
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
Intervention: 5mm spring clip (Device)
Outcomes
Primary Outcomes
No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
Time Frame: By post op day one HIDA scan.
Secondary Outcomes
- 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.)