Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.
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About
The investigators will collect the pre-operative medical history and arrange physical examination, life quality evaluation, blood and biochemical test. The Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study. Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In study group , ICG was give by intra-gallbladder injection or systemic injection, the cholecystectomy were performed . In control group, no ICG was given and traditional cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded. Conversion rate, post-operative morbidity and mortality will be recorded as well .
Full description
Back Ground:
Laparoscopic cholecystectomy(LC) is the one of most common procedure done by minimal invasive surgery worldwide but the common bile duct(CBD) injury still happened even the existence of standard technique with growing experience and new technology, especial in cholecystitis. Image guided surgery created new concept for fluorescent cholangiography to demonstrate the anatomy of CBD by using indocyanine green (ICG) intravenous injection before operation to decreased complication. The result is positive but the border of gallbladder can't be seen very well in systemic injection . In cholecystitis, the border between gallbladder and common bile duct is important as well as CBD and cystic duct.
Purpose:
The investigators hypothesized injection of ICG into gallbladder directly will be helpful to identify cystic duct, CBD and the border of gallbladder as well as systemic injection . The purpose of this study was to evaluate feasibility of this image guide surgery
Study Design:
The investigators will collect the pre-operative medical history and arrange physical examination, life quality evaluation, blood and biochemical test. The Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study. Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In study group , ICG was give by intra-gallbladder injection or systemic injection, the cholecystectomy were performed . In control group, no ICG was given and traditional cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was started from cystic duct in Calot's triangle. Time to gallbladder removed was recorded. Conversion rate, post-operative morbidity and mortality will be recorded as well . The investigators intend to collect 600 patients. 150 patients will receive ICG injection via gallbladder as image guided surgery, 150 patients will receive ICG injection via systemic injection as image guided surgery , the other 300 patients who refuse will be the control group(150 patients for LC and 150 patients for LC + intra-operative cholangiography).
Expected results A. Publish Intra-gallbladder indocyanide green injection via drainage route facilitate cholecystectomy in acute cholecystitis。 B. Publish Comparison of systemic and intra-gallbladder injection of indocyanide green in benefit for cholecystectomy C. Extend to publish Near-infrared cholangiography decreased learning curve of laparoscopic cholecystectomy for medical student D. Near- infrared laparoscope education textbook and clinical case analysis
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Inclusion criteria
- Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.
Exclusion criteria
- a.Pregnancy and Breast feeding female.
- b.Patients have another severe medical diseases.(ex: heart failure, respiratory failure and stroke etc.)
- c.Not suitable for patients receiving anesthesia.
- d.Alcoholism, drug abuse and psychopaths.
- e.Iodine allergies and renal failure patients.
Trial design
Primary purpose
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Interventional model
Masking
600 participants in 4 patient groups
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Central trial contact
Ta-Sen Yeh, PhD; Yu-Yin Liu, MD
Data sourced from clinicaltrials.gov
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