Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Not Applicable
- Conditions
- gallbladder stone chronic cholesistitis chlesistic polyp
- Registration Number
- JPRN-UMIN000024705
- Lead Sponsor
- Cleveland Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Not provided
Exclusion Criteria
1. Known allergies to iodides 2. Known history of coagulopathy 3. Known moderate or severe liver disease 4. Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection Rate (DR) of each particular extra-hepatobiliary structure during Laparoscopic Cholecystectomy (LC) defined as the total number of patients in which the particular structure is detected before and after dissection in that arm of the Study (WLI or NIFC), divided by the total number of patients in that arm. Extra-hepatobiliary structures to be included in this assessment: Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts
- Secondary Outcome Measures
Name Time Method 1. The DR for students/residents only (apart from experienced surgeons), both before and after dissection. 2. Time to Clip or Tie the Cystic Duct 3. Incidence Rate of Conversion to Open Surgery 4. Estimated Blood Loss 5. Incidence Rate of Bile Leakage 6. Incidence Rate of Bile Duct Injury (BDI) 7. Surgeon Confidence Level