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Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.

Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03024892
Enrollment
600
Registered
2017-01-19
Start date
2015-11-30
Completion date
2018-10-31
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluorenscent Image Guided Surgery, Indocyanide Green

Keywords

Fluorenscent image guided surgery, indocyanide green, laparoscopic cholecystectomy, common bile duct injury

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 .

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

PROCEDUREICG GB

ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.

PROCEDUREICG IV

ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.

PROCEDURELC conventional

simple laparoscopic cholecystectomy was performed under white light image.

PROCEDURELC conventional and IOC

simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
conversion rateintra-operative periodthe rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy
CBD identification ( white light and infrared fluroscence image)intra-operative periodevaluation rate the visualization of Hartmann's pouch between two method
Hartmann's pouch identification ( white light and infrared fluroscence image)intra-operative periodevaluation rate the visualization of Hartmann's pouch between two method
CHD identification ( white light and infrared fluroscence image)intra-operative periodevaluation rate the visualization of Hartmann's pouch between two method
Cystic duct identification ( white light and infrared fluroscence image)intra-operative periodevaluation rate the visualization of Hartmann's pouch between two method

Secondary

MeasureTime frameDescription
Post op morbidityPost op day 7any complication related to surgery
Post op mortalityPost op day 30any mortality related to surgery
CBD injurypost op day 3evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination

Countries

Taiwan

Contacts

Primary ContactYu-Yin Liu, MD
liuyuyin5750@gmail.com+886975365627
Backup ContactTa-Sen Yeh, PhD
tsy471027@cgmh.org.tw+886975368190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026