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Insufficient funding to complete study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spring Clips | Other | Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5mm spring clip | Device | Microline Pentax 5mm Visu-Loc Clip Applier |
|
| Measure | Description | 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. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Ramshaw, MD | Chief, Division of General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Hospital and Clinics | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan. | Posted | Count of Participants | Participants | By post op day one HIDA scan. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Study was terminated before expected enrollment was reached due to insufficient funds.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Ramshaw, M.D. | University of Missouri Health Care | 5738841925 | kadysj@health.missouri.edu |
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| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security. | Data not collected. | Posted | By post op day one HIDA scan. |
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| 0 |
| 14 |
| 0 |
| 14 |
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