Healthy
Conditions
Keywords
biliary leaks after laparoscopic cholecystectomy
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.
Interventions
DEVICE5mm spring clip
Microline Pentax 5mm Visu-Loc Clip Applier
Sponsors
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan. | By post op day one HIDA scan. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spring Clips Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Spring Clips |
|---|---|
| Age, Customized > 18 years | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex/Gender, Customized Unknown | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spring Clips | No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan. | 14 Participants |
Secondary
Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.
Time frame: By post op day one HIDA scan.
Population: Data not collected.