Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.

Overview

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 Title of Study: “Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2018

Detailed 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

Interventions

  • Procedure: ICG GB
    • ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
  • Procedure: ICG IV
    • ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
  • Procedure: LC conventional
    • simple laparoscopic cholecystectomy was performed under white light image.
  • Procedure: LC conventional and IOC
    • simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.

Arms, Groups and Cohorts

  • Experimental: ICG gallbladder
    • patients who received ICG injection via gallbladder and received fluroscence image guided surgery
  • Experimental: ICG IV
    • patients who received ICG injection via peripheral vein and received fluroscence image guided surgery
  • Sham Comparator: LC conventional
    • Patients received conventional laparoscopic cholecystectomy
  • Sham Comparator: LC conventional and IOC
    • Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography

Clinical Trial Outcome Measures

Primary Measures

  • Hartmann’s pouch identification ( white light and infrared fluroscence image)
    • Time Frame: intra-operative period
    • evaluation rate the visualization of Hartmann’s pouch between two method
  • Cystic duct identification ( white light and infrared fluroscence image)
    • Time Frame: intra-operative period
    • evaluation rate the visualization of Hartmann’s pouch between two method
  • CBD identification ( white light and infrared fluroscence image)
    • Time Frame: intra-operative period
    • evaluation rate the visualization of Hartmann’s pouch between two method
  • CHD identification ( white light and infrared fluroscence image)
    • Time Frame: intra-operative period
    • evaluation rate the visualization of Hartmann’s pouch between two method
  • conversion rate
    • Time Frame: intra-operative period
    • the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy

Secondary Measures

  • CBD injury
    • Time Frame: post op day 3
    • evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination
  • Post op morbidity
    • Time Frame: Post op day 7
    • any complication related to surgery
  • Post op mortality
    • Time Frame: Post op day 30
    • any mortality related to surgery

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chien-Hung Liao, MD, Principal Investigator, Chang Gung Memorial Hospital
    • Shang-Yu Wang, MD, Principal Investigator, Chang Gung Memorial Hospital
  • Overall Contact(s)
    • Yu-Yin Liu, MD, +886975365627, liuyuyin5750@gmail.com

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