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Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.

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ClinicalTrials.gov Identifier: NCT03024892
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Fluorenscent Image Guided Surgery Indocyanide Green Procedure: ICG GB Procedure: ICG IV Procedure: LC conventional Procedure: LC conventional and IOC Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.
Study Start Date : November 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICG gallbladder
patients who received ICG injection via gallbladder and received fluroscence image guided surgery
Procedure: ICG GB
ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.

Experimental: ICG IV
patients who received ICG injection via peripheral vein and received fluroscence image guided surgery
Procedure: ICG IV
ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.

Sham Comparator: LC conventional
Patients received conventional laparoscopic cholecystectomy
Procedure: LC conventional
simple laparoscopic cholecystectomy was performed under white light image.

Sham Comparator: LC conventional and IOC
Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography
Procedure: LC conventional and IOC
simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.




Primary Outcome Measures :
  1. 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

  2. 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

  3. CBD identification ( white light and infrared fluroscence image) [ Time Frame: intra-operative period ]
    evaluation rate the visualization of Hartmann's pouch between two method

  4. CHD identification ( white light and infrared fluroscence image) [ Time Frame: intra-operative period ]
    evaluation rate the visualization of Hartmann's pouch between two method

  5. conversion rate [ Time Frame: intra-operative period ]
    the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy


Secondary Outcome Measures :
  1. CBD injury [ Time Frame: post op day 3 ]
    evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination

  2. Post op morbidity [ Time Frame: Post op day 7 ]
    any complication related to surgery

  3. Post op mortality [ Time Frame: Post op day 30 ]
    any mortality related to surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024892


Contacts
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Contact: Yu-Yin Liu, MD +886975365627 liuyuyin5750@gmail.com
Contact: Ta-Sen Yeh, PhD +886975368190 tsy471027@cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Niaosong, Kaohsiung, Taiwan, 833
Contact: Yu-Yin Liu, MD    +886975365627    liuyuyin5750@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chien-Hung Liao, MD Chang Gung Memorial Hospital
Principal Investigator: Shang-Yu Wang, MD Chang Gung Memorial Hospital

Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03024892     History of Changes
Other Study ID Numbers: CGMH-IRB-104-5333A3
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Chang Gung Memorial Hospital:
Fluorenscent image guided surgery
indocyanide green
laparoscopic cholecystectomy
common bile duct injury