Fluorenscent Image Guided SurgeryNCT03024892
Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.
A study testing ICG GB, ICG IV and LC conventional in people with Fluorenscent Image Guided Surgery and Indocyanide Green, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Fluorenscent Image Guided Surgery, Indocyanide Green
- What is being tested?
- ICG GB, ICG IV and LC conventional
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Niaosong, Kaohsiung, 833
Yu-Yin Liu, MD, +886975365627, liuyuyin5750@gmail.com
About this study
Official title: Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.
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 .
Read the 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
- Being tested
- ICG GB, ICG IV, LC conventional, LC conventional and IOC
- Keywords
- Fluorenscent image guided surgery, indocyanide green, laparoscopic cholecystectomy, common bile duct injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG GBProcedure or surgery
ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
ICG IVProcedure or surgery
ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
LC conventionalProcedure or surgery
simple laparoscopic cholecystectomy was performed under white light image.
LC conventional and IOCProcedure or surgery
simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.
| Study group | Role | What they receive |
|---|---|---|
| ICG gallbladder | Experimental | patients who received ICG injection via gallbladder and received fluroscence image guided surgery Receives: Procedure: ICG GB |
| ICG IV | Experimental | patients who received ICG injection via peripheral vein and received fluroscence image guided surgery Receives: Procedure: ICG IV |
| LC conventional | Sham comparator | Patients received conventional laparoscopic cholecystectomy Receives: Procedure: LC conventional |
| LC conventional and IOC | Sham comparator | Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography Receives: Procedure: LC conventional and IOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hartmann's pouch identification ( white light and infrared fluroscence image)
evaluation rate the visualization of Hartmann's pouch between two method
Measured: intra-operative period
Cystic duct identification ( white light and infrared fluroscence image)
evaluation rate the visualization of Hartmann's pouch between two method
Measured: intra-operative period
CBD identification ( white light and infrared fluroscence image)
evaluation rate the visualization of Hartmann's pouch between two method
Measured: intra-operative period
CHD identification ( white light and infrared fluroscence image)
evaluation rate the visualization of Hartmann's pouch between two method
Measured: intra-operative period
conversion rate
the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy
Measured: intra-operative period
Secondary outcomes (3)
CBD injury
evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination
Measured: post op day 3
Post op morbidity
any complication related to surgery
Measured: Post op day 7
Post op mortality
any mortality related to surgery
Measured: Post op day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Fluorenscent Image Guided SurgeryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Hung Liao, MD, Principal investigator, Chang Gung Memorial HospitalShang-Yu Wang, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024892
- Sponsor's protocol ID
- CGMH-IRB-104-5333A3
- Status last verified
- Jul 2018
- First submitted
- 17 Jan 2017
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Avgerinos C, Kelgiorgi D, Touloumis Z, Baltatzi L, Dervenis C. One thousand laparoscopic cholecystectomies in a single surgical unit using the "critical view of safety" technique. J Gastrointest Surg. 2009 Mar;13(3):498-503. doi: 10.1007/s11605-008-0748-8. Epub 2008 Nov 14.
PubMed 19009323Paczynski A, Koziarski T, Stanowski E, Krupa J. Extrahepatic bile duct injury during laparoscopic cholecystectomy -- own material. Med Sci Monit. 2002 Jun;8(6):CR438-40.
PubMed 12070436Shea JA, Healey MJ, Berlin JA, Clarke JR, Malet PF, Staroscik RN, Schwartz JS, Williams SV. Mortality and complications associated with laparoscopic cholecystectomy. A meta-analysis. Ann Surg. 1996 Nov;224(5):609-20. doi: 10.1097/00000658-199611000-00005.
PubMed 8916876Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
PubMed 24022431Zafar SN, Obirieze A, Adesibikan B, Cornwell EE 3rd, Fullum TM, Tran DD. Optimal time for early laparoscopic cholecystectomy for acute cholecystitis. JAMA Surg. 2015 Feb;150(2):129-36. doi: 10.1001/jamasurg.2014.2339.
PubMed 25517723Viste A, Jensen D, Angelsen JH, Hoem D. Percutaneous cholecystostomy in acute cholecystitis; a retrospective analysis of a large series of 104 patients. BMC Surg. 2015 Mar 8;15:17. doi: 10.1186/s12893-015-0002-8.
PubMed 25872885Suzuki K, Bower M, Cassaro S, Patel RI, Karpeh MS, Leitman IM. Tube cholecystostomy before cholecystectomy for the treatment of acute cholecystitis. JSLS. 2015 Jan-Mar;19(1):e2014.00200. doi: 10.4293/JSLS.2014.00200.
PubMed 25848180Mir IS, Mohsin M, Kirmani O, Majid T, Wani K, Hassan MU, Naqshbandi J, Maqbool M. Is intra-operative cholangiography necessary during laparoscopic cholecystectomy? A multicentre rural experience from a developing world country. World J Gastroenterol. 2007 Sep 7;13(33):4493-7. doi: 10.3748/wjg.v13.i33.4493.
PubMed 17724807Kaczynski J, Hilton J. A gallbladder with the "hidden cystic duct": A brief overview of various surgical techniques of the Calot's triangle dissection. Interv Med Appl Sci. 2015 Mar;7(1):42-5. doi: 10.1556/IMAS.7.2015.1.4. Epub 2015 Mar 20.
PubMed 25838927Sanjay P, Fulke JL, Exon DJ. 'Critical view of safety' as an alternative to routine intraoperative cholangiography during laparoscopic cholecystectomy for acute biliary pathology. J Gastrointest Surg. 2010 Aug;14(8):1280-4. doi: 10.1007/s11605-010-1251-6. Epub 2010 Jun 10.
PubMed 20535578Sanjay P, Kulli C, Polignano FM, Tait IS. Optimal surgical technique, use of intra-operative cholangiography (IOC), and management of acute gallbladder disease: the results of a nation-wide survey in the UK and Ireland. Ann R Coll Surg Engl. 2010 May;92(4):302-6. doi: 10.1308/003588410X12628812458617.
PubMed 20501016Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V, Soler L, Barry B, Namer IJ, Demartines N, Charles AL, Geny B, Marescaux J. Enhanced-reality video fluorescence: a real-time assessment of intestinal viability. Ann Surg. 2014 Apr;259(4):700-7. doi: 10.1097/SLA.0b013e31828d4ab3.
PubMed 23532109Kong SH, Noh YW, Suh YS, Park HS, Lee HJ, Kang KW, Kim HC, Lim YT, Yang HK. Evaluation of the novel near-infrared fluorescence tracers pullulan polymer nanogel and indocyanine green/gamma-glutamic acid complex for sentinel lymph node navigation surgery in large animal models. Gastric Cancer. 2015 Jan;18(1):55-64. doi: 10.1007/s10120-014-0345-3. Epub 2014 Jan 31.
PubMed 24481855Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.
PubMed 25303914Ishizawa T, Bandai Y, Ijichi M, Kaneko J, Hasegawa K, Kokudo N. Fluorescent cholangiography illuminating the biliary tree during laparoscopic cholecystectomy. Br J Surg. 2010 Sep;97(9):1369-77. doi: 10.1002/bjs.7125.
PubMed 20623766
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.
- ClinicalTrials.gov ID
- NCT03024892
- Acronym / sponsor ID
- CGMH-IRB-104-5333A3
- Keywords
- Fluorenscent image guided surgery, indocyanide green, laparoscopic cholecystectomy, common bile duct injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICG gallbladder | Experimental | Procedure: ICG GBpatients who received ICG injection via gallbladder and received fluroscence image guided surgery |
| ICG IV | Experimental | Procedure: ICG IVpatients who received ICG injection via peripheral vein and received fluroscence image guided surgery |
| LC conventional | Sham comparator | Procedure: LC conventionalPatients received conventional laparoscopic cholecystectomy |
| LC conventional and IOC | Sham comparator | Procedure: LC conventional and IOCPatients received conventional laparoscopic cholecystectomy + intraoperative cholangiography |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG GBICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed. | Procedure or surgery | ICG gallbladder |
| ICG IVICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed. | Procedure or surgery | ICG IV |
| LC conventionalsimple laparoscopic cholecystectomy was performed under white light image. | Procedure or surgery | LC conventional |
| LC conventional and IOCsimple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance. | Procedure or surgery | LC conventional and IOC |
Primary outcome
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
3 secondary outcomes
CBD injury
Time frame: post op day 3
Post op morbidity
Time frame: Post op day 7
Post op mortality
Time frame: Post op day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Background: PubMed 19009323Avgerinos C, Kelgiorgi D, Touloumis Z, Baltatzi L, Dervenis C. One thousand laparoscopic cholecystectomies in a single surgical unit using the "critical view of safety" technique. J Gastrointest Surg. 2009 Mar;13(3):498-503. doi: 10.1007/s11605-008-0748-8. Epub 2008 Nov 14.
- Background: PubMed 12070436Paczynski A, Koziarski T, Stanowski E, Krupa J. Extrahepatic bile duct injury during laparoscopic cholecystectomy -- own material. Med Sci Monit. 2002 Jun;8(6):CR438-40.
- Background: PubMed 8916876Shea JA, Healey MJ, Berlin JA, Clarke JR, Malet PF, Staroscik RN, Schwartz JS, Williams SV. Mortality and complications associated with laparoscopic cholecystectomy. A meta-analysis. Ann Surg. 1996 Nov;224(5):609-20. doi: 10.1097/00000658-199611000-00005.
- Background: PubMed 24022431Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
- Background: PubMed 25517723Zafar SN, Obirieze A, Adesibikan B, Cornwell EE 3rd, Fullum TM, Tran DD. Optimal time for early laparoscopic cholecystectomy for acute cholecystitis. JAMA Surg. 2015 Feb;150(2):129-36. doi: 10.1001/jamasurg.2014.2339.
- Background: PubMed 25872885Viste A, Jensen D, Angelsen JH, Hoem D. Percutaneous cholecystostomy in acute cholecystitis; a retrospective analysis of a large series of 104 patients. BMC Surg. 2015 Mar 8;15:17. doi: 10.1186/s12893-015-0002-8.
- Background: PubMed 25848180Suzuki K, Bower M, Cassaro S, Patel RI, Karpeh MS, Leitman IM. Tube cholecystostomy before cholecystectomy for the treatment of acute cholecystitis. JSLS. 2015 Jan-Mar;19(1):e2014.00200. doi: 10.4293/JSLS.2014.00200.
- Background: PubMed 17724807Mir IS, Mohsin M, Kirmani O, Majid T, Wani K, Hassan MU, Naqshbandi J, Maqbool M. Is intra-operative cholangiography necessary during laparoscopic cholecystectomy? A multicentre rural experience from a developing world country. World J Gastroenterol. 2007 Sep 7;13(33):4493-7. doi: 10.3748/wjg.v13.i33.4493.
- Background: PubMed 25838927Kaczynski J, Hilton J. A gallbladder with the "hidden cystic duct": A brief overview of various surgical techniques of the Calot's triangle dissection. Interv Med Appl Sci. 2015 Mar;7(1):42-5. doi: 10.1556/IMAS.7.2015.1.4. Epub 2015 Mar 20.
- Background: PubMed 20535578Sanjay P, Fulke JL, Exon DJ. 'Critical view of safety' as an alternative to routine intraoperative cholangiography during laparoscopic cholecystectomy for acute biliary pathology. J Gastrointest Surg. 2010 Aug;14(8):1280-4. doi: 10.1007/s11605-010-1251-6. Epub 2010 Jun 10.
- Background: PubMed 20501016Sanjay P, Kulli C, Polignano FM, Tait IS. Optimal surgical technique, use of intra-operative cholangiography (IOC), and management of acute gallbladder disease: the results of a nation-wide survey in the UK and Ireland. Ann R Coll Surg Engl. 2010 May;92(4):302-6. doi: 10.1308/003588410X12628812458617.
- Background: PubMed 23532109Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V, Soler L, Barry B, Namer IJ, Demartines N, Charles AL, Geny B, Marescaux J. Enhanced-reality video fluorescence: a real-time assessment of intestinal viability. Ann Surg. 2014 Apr;259(4):700-7. doi: 10.1097/SLA.0b013e31828d4ab3.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hung Liao, MD principal investigator
Chang Gung Memorial Hospital
Shang-Yu Wang, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG GB, ICG IV and LC conventional in people with Fluorenscent Image Guided Surgery and Indocyanide Green, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Yin Liu, MD (+886975365627, liuyuyin5750@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hartmann's pouch identification ( white light and infrared fluroscence image) (time frame: intra-operative period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03024892, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.