<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024892</url>
  </required_header>
  <id_info>
    <org_study_id>CGMH-IRB-104-5333A3</org_study_id>
    <nct_id>NCT03024892</nct_id>
  </id_info>
  <brief_title>Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.</brief_title>
  <official_title>Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will collect the pre-operative medical history and arrange physical&#xD;
      examination, life quality evaluation, blood and biochemical test. The Patients with acute&#xD;
      cholecytitis, gallstone or gallbladder polyp without interventional treatment or&#xD;
      cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.&#xD;
      Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In&#xD;
      study group , ICG was give by intra-gallbladder injection or systemic injection, the&#xD;
      cholecystectomy were performed . In control group, no ICG was given and traditional&#xD;
      cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the&#xD;
      ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before&#xD;
      cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was&#xD;
      started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded.&#xD;
      Conversion rate, post-operative morbidity and mortality will be recorded as well .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Back Ground:&#xD;
&#xD;
      Laparoscopic cholecystectomy(LC) is the one of most common procedure done by minimal invasive&#xD;
      surgery worldwide but the common bile duct(CBD) injury still happened even the existence of&#xD;
      standard technique with growing experience and new technology, especial in cholecystitis.&#xD;
      Image guided surgery created new concept for fluorescent cholangiography to demonstrate the&#xD;
      anatomy of CBD by using indocyanine green (ICG) intravenous injection before operation to&#xD;
      decreased complication. The result is positive but the border of gallbladder can't be seen&#xD;
      very well in systemic injection . In cholecystitis, the border between gallbladder and common&#xD;
      bile duct is important as well as CBD and cystic duct.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
      The investigators hypothesized injection of ICG into gallbladder directly will be helpful to&#xD;
      identify cystic duct, CBD and the border of gallbladder as well as systemic injection . The&#xD;
      purpose of this study was to evaluate feasibility of this image guide surgery&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      The investigators will collect the pre-operative medical history and arrange physical&#xD;
      examination, life quality evaluation, blood and biochemical test. The Patients with acute&#xD;
      cholecytitis, gallstone or gallbladder polyp without interventional treatment or&#xD;
      cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.&#xD;
      Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In&#xD;
      study group , ICG was give by intra-gallbladder injection or systemic injection, the&#xD;
      cholecystectomy were performed . In control group, no ICG was given and traditional&#xD;
      cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the&#xD;
      ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before&#xD;
      cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was&#xD;
      started from cystic duct in Calot's triangle. Time to gallbladder removed was recorded.&#xD;
      Conversion rate, post-operative morbidity and mortality will be recorded as well . The&#xD;
      investigators intend to collect 600 patients. 150 patients will receive ICG injection via&#xD;
      gallbladder as image guided surgery, 150 patients will receive ICG injection via systemic&#xD;
      injection as image guided surgery , the other 300 patients who refuse will be the control&#xD;
      group(150 patients for LC and 150 patients for LC + intra-operative cholangiography).&#xD;
&#xD;
      Expected results A. Publish Intra-gallbladder indocyanide green injection via drainage route&#xD;
      facilitate cholecystectomy in acute cholecystitis。 B. Publish Comparison of systemic and&#xD;
      intra-gallbladder injection of indocyanide green in benefit for cholecystectomy C. Extend to&#xD;
      publish Near-infrared cholangiography decreased learning curve of laparoscopic&#xD;
      cholecystectomy for medical student D. Near- infrared laparoscope education textbook and&#xD;
      clinical case analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hartmann's pouch identification ( white light and infrared fluroscence image)</measure>
    <time_frame>intra-operative period</time_frame>
    <description>evaluation rate the visualization of Hartmann's pouch between two method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cystic duct identification ( white light and infrared fluroscence image)</measure>
    <time_frame>intra-operative period</time_frame>
    <description>evaluation rate the visualization of Hartmann's pouch between two method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CBD identification ( white light and infrared fluroscence image)</measure>
    <time_frame>intra-operative period</time_frame>
    <description>evaluation rate the visualization of Hartmann's pouch between two method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CHD identification ( white light and infrared fluroscence image)</measure>
    <time_frame>intra-operative period</time_frame>
    <description>evaluation rate the visualization of Hartmann's pouch between two method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>conversion rate</measure>
    <time_frame>intra-operative period</time_frame>
    <description>the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CBD injury</measure>
    <time_frame>post op day 3</time_frame>
    <description>evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post op morbidity</measure>
    <time_frame>Post op day 7</time_frame>
    <description>any complication related to surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post op mortality</measure>
    <time_frame>Post op day 30</time_frame>
    <description>any mortality related to surgery</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Fluorenscent Image Guided Surgery</condition>
  <condition>Indocyanide Green</condition>
  <arm_group>
    <arm_group_label>ICG gallbladder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who received ICG injection via gallbladder and received fluroscence image guided surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICG IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who received ICG injection via peripheral vein and received fluroscence image guided surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LC conventional</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients received conventional laparoscopic cholecystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LC conventional and IOC</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ICG GB</intervention_name>
    <description>ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.</description>
    <arm_group_label>ICG gallbladder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ICG IV</intervention_name>
    <description>ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.</description>
    <arm_group_label>ICG IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LC conventional</intervention_name>
    <description>simple laparoscopic cholecystectomy was performed under white light image.</description>
    <arm_group_label>LC conventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LC conventional and IOC</intervention_name>
    <description>simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.</description>
    <arm_group_label>LC conventional and IOC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute cholecytitis, gallstone or gallbladder polyp without&#xD;
             interventional treatment or cholecystitis after percurtaneus gallbladder&#xD;
             drainage(PTGBD) were involved in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a.Pregnancy and Breast feeding female.&#xD;
&#xD;
          -  b.Patients have another severe medical diseases.(ex: heart failure, respiratory&#xD;
             failure and stroke etc.)&#xD;
&#xD;
          -  c.Not suitable for patients receiving anesthesia.&#xD;
&#xD;
          -  d.Alcoholism, drug abuse and psychopaths.&#xD;
&#xD;
          -  e.Iodine allergies and renal failure patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Hung Liao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shang-Yu Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu-Yin Liu, MD</last_name>
    <phone>+886975365627</phone>
    <email>liuyuyin5750@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ta-Sen Yeh, PhD</last_name>
    <phone>+886975368190</phone>
    <email>tsy471027@cgmh.org.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Niaosong</city>
        <state>Kaohsiung</state>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu-Yin Liu, MD</last_name>
      <phone>+886975365627</phone>
      <email>liuyuyin5750@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Avgerinos C, Kelgiorgi D, Touloumis Z, Baltatzi L, Dervenis C. One thousand laparoscopic cholecystectomies in a single surgical unit using the &quot;critical view of safety&quot; technique. J Gastrointest Surg. 2009 Mar;13(3):498-503. doi: 10.1007/s11605-008-0748-8. Epub 2008 Nov 14.</citation>
    <PMID>19009323</PMID>
  </reference>
  <reference>
    <citation>Paczynski 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.</citation>
    <PMID>12070436</PMID>
  </reference>
  <reference>
    <citation>Shea 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.</citation>
    <PMID>8916876</PMID>
  </reference>
  <reference>
    <citation>Gutt 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.</citation>
    <PMID>24022431</PMID>
  </reference>
  <reference>
    <citation>Zafar 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. Erratum In: JAMA Surg. 2015 Feb;150(2):183.</citation>
    <PMID>25517723</PMID>
  </reference>
  <reference>
    <citation>Viste 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.</citation>
    <PMID>25872885</PMID>
  </reference>
  <reference>
    <citation>Suzuki 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.</citation>
    <PMID>25848180</PMID>
  </reference>
  <reference>
    <citation>Mir 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.</citation>
    <PMID>17724807</PMID>
  </reference>
  <reference>
    <citation>Kaczynski J, Hilton J. A gallbladder with the &quot;hidden cystic duct&quot;: 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.</citation>
    <PMID>25838927</PMID>
  </reference>
  <reference>
    <citation>Sanjay 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.</citation>
    <PMID>20535578</PMID>
  </reference>
  <reference>
    <citation>Sanjay 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.</citation>
    <PMID>20501016</PMID>
  </reference>
  <reference>
    <citation>Diana 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.</citation>
    <PMID>23532109</PMID>
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  <reference>
    <citation>Kong 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.</citation>
    <PMID>24481855</PMID>
  </reference>
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    <citation>Boni 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.</citation>
    <PMID>25303914</PMID>
  </reference>
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    <citation>Ishizawa 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.</citation>
    <PMID>20623766</PMID>
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    <citation>Schols RM, Bouvy ND, van Dam RM, Masclee AA, Dejong CH, Stassen LP. Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013 Dec;27(12):4511-7. doi: 10.1007/s00464-013-3100-7. Epub 2013 Jul 23.</citation>
    <PMID>23877766</PMID>
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    <citation>Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol. 2010 Jun 29;8(6):e1000412. doi: 10.1371/journal.pbio.1000412. No abstract available.</citation>
    <PMID>20613859</PMID>
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  <reference>
    <citation>Liu YY, Pop R, Diana M, Kong SH, Legner A, Beaujeux R, Marescaux J. Real-time fluorescence angiography by intra-arterial indocyanine green injection to identify obscure gastrointestinal bleeding territory: proof of concept in the porcine model. Surg Endosc. 2016 May;30(5):2143-50. doi: 10.1007/s00464-015-4460-y. Epub 2015 Aug 15.</citation>
    <PMID>26275550</PMID>
  </reference>
  <reference>
    <citation>Liu YY, Kong SH, Diana M, Legner A, Wu CC, Kameyama N, Dallemagne B, Marescaux J. Near-infrared cholecysto-cholangiography with indocyanine green may secure cholecystectomy in difficult clinical situations: proof of the concept in a porcine model. Surg Endosc. 2016 Sep;30(9):4115-23. doi: 10.1007/s00464-015-4608-9. Epub 2015 Oct 28.</citation>
    <PMID>26511116</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluorenscent image guided surgery</keyword>
  <keyword>indocyanide green</keyword>
  <keyword>laparoscopic cholecystectomy</keyword>
  <keyword>common bile duct injury</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024892
org study id: CGMH-IRB-104-5333A3
nct id: NCT03024892
lead sponsor: 
has dmc: Yes
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 .
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
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hartmann's pouch identification ( white light and infrared fluroscence image)
time frame: intra-operative period
description: evaluation rate the visualization of Hartmann's pouch between two method
measure: Cystic duct identification ( white light and infrared fluroscence image)
time frame: intra-operative period
description: evaluation rate the visualization of Hartmann's pouch between two method
measure: CBD identification ( white light and infrared fluroscence image)
time frame: intra-operative period
description: evaluation rate the visualization of Hartmann's pouch between two method
measure: CHD identification ( white light and infrared fluroscence image)
time frame: intra-operative period
description: evaluation rate the visualization of Hartmann's pouch between two method
measure: conversion rate
time frame: intra-operative period
description: the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy
measure: CBD injury
time frame: post op day 3
description: evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination
measure: Post op morbidity
time frame: Post op day 7
description: any complication related to surgery
measure: Post op mortality
time frame: Post op day 30
description: any mortality related to surgery
arm group label: ICG gallbladder
arm group type: Experimental
description: patients who received ICG injection via gallbladder and received fluroscence image guided surgery
arm group label: ICG IV
arm group type: Experimental
description: patients who received ICG injection via peripheral vein and received fluroscence image guided surgery
arm group label: LC conventional
arm group type: Sham Comparator
description: Patients received conventional laparoscopic cholecystectomy
arm group label: LC conventional and IOC
arm group type: Sham Comparator
description: Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography
intervention type: Procedure
intervention name: ICG GB
description: ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
arm group label: ICG gallbladder
intervention type: Procedure
intervention name: ICG IV
description: ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
arm group label: ICG IV
intervention type: Procedure
intervention name: LC conventional
description: simple laparoscopic cholecystectomy was performed under white light image.
arm group label: LC conventional
intervention type: Procedure
intervention name: LC conventional and IOC
description: simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.
arm group label: LC conventional and IOC
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Chien-Hung Liao, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Shang-Yu Wang, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Yu-Yin Liu, MD
phone: +886975365627
email: liuyuyin5750@gmail.com
last name: Ta-Sen Yeh, PhD
phone: +886975368190
email: tsy471027@cgmh.org.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
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responsible party type: Sponsor
sharing ipd: Yes