Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

University of Missouri (MU)

Status: Terminated

Conditions: Healthy

Treatments: Device: 5mm spring clip

Study type: Interventional

Funder types: Other

Identifiers

NCT00527644

1090979

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Spring Clips

Other group

Description:

Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.

Treatment:

Device: 5mm spring clip