Hepatic CarcinomaNCT04266548
Arterial Base Fluorescence Segmental Positive Staining
A study testing Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining in people with Hepatic Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
More and more laparoscopic hepatectomy were performed due to increasing experience, well designed instruments and energy device. But the localization of tumor and resection line design are still relative difficult comparing open approach due to limit space. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatic Carcinoma
- What is being tested?
- Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2018to 6 Jan 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single Hepatocellular carcinoma.
- plan of Laparoscopic hepatectomy.
- Age between 20 to 85 y/o.
Who cannot join
- allergies to iodine or ICG
- Liver cirrhosis
- coagulopathy
- chronic kidney disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
More and more laparoscopic hepatectomy were performed due to increasing experience, well designed instruments and energy device. But the localization of tumor and resection line design are still relative difficult comparing open approach due to limit space. Intraoperative liver segmentation can be obtained by ultrasound-guide intraportal injection of a fluorophore and illuminating with a Near-Infrared light source for positive staining and by intravenous injection after ligation of segmental vessels for negative staining .The ultrasound guide intraportal injection approach is challenging in the minimally-invasive setting. However hepatocelluar carcinoma(HCC) was supplied by hepatic artery mainly. The investigators aimed to evaluate the feasibility of arterial base positive staining for fluorescence liver segmentation in human by superselective intra-hepatic artery injection of Indocyanine Green (ICG) .
Read the detailed description
Materials and Methods
- Participants The present prospective, single-center, feasibility study of fluorescence demarcation of hepatic segment including HCC by means of direct super-selective intrahepatic artery ICG injection. Patients were enrolled according to the following criteria: single HCC, scheduled for laparoscopic hepatectomy for curative resection, age ranging from 20 to 85 years old, absence of proven or suspected allergies to iodine or ICG, absence of coagulopathy, absence of diseases contraindicating general anesthesia, and absence of pregnancy. All the bio-chemical test, cardiac echo , cardiac thalium test, ICG clearance test, Liver CT or MRI were obtained before operation
- Equipment Endovascular procedure was performed in the conventional angiography room and laparoscopic hepatecotmy was done in operating room at the Kaohsiung Chang Gung memorial hospital. Near infra-red fluorescence laparoscopy was used to acquire the fluorescence signal arising from the liver parenchyma after Indocyanine Green (ICG) injection.
- Procedures
- Celiac trunk angiography and super-selective hepatic angiography: A 4 Fr angiography sheath (Terumo Europe NV, Belgium) was placed under aseptic conditions in the right femoral artery, using the Seldinger technique. A 4 Fr Cobra-2 catheter (Terumo Europe NV, Belgium) was positioned at the origin of the celiac trunk. A selective celiac trunk digital subtraction angiographic (DSA) run was performed, after injection of a contrast medium (Visipaque 270, GE Healthcare; Buckinghamshire, United Kingdom), 28mL at a rate of 4mL/sec. A 2.7 French micro-catheter (Progreat™, Terumo Europe NV; Belgium) was used to super-selectively catheterize different hepatic segmental arteries supplying the target hepatic segment including HCC. In all cases, the position was controlled by performing DSA and angio computer tomography runs with selective micro-catheter injections. The micro-catheter was then perfused with saline and left in place until surgery. Then the patients were transferred to operative room while operative room available.
- Evaluation of hepatic segmental demarcation using NIR real-time imaging during laparoscopic hepatectomy:
The patients underwent a standard 5-port laparoscopic hepatectomy, which was performed by 2 experienced laparoscopic surgeons .
Stage I : the liver mobilization was performed for preparing the hepatectomy. The intraoperative ultrasound was used for localization of HCC. The resection line was defined as principle of laparoscopic hepatectomy such as surgical margin, surgical volume and etc. The pringle control device was prepared.
Stage II : Rea-time enhanced visualization of the hepatic segment which were supplied feeding artery was achieved by means of fluorescence imaging using a direct selective intrahepatic artery injection of a 5 mL bolus of ICG (DiagnoGreen®, Taiwan, ROC) at a concentration of 0.125mg/mL. The demarcation of enhanced hepatic segment were defined. The correspondence between the fluorescence margin and ultrasound(US) guide resection line were analized.
Stage III: The surgical resection line was chose by real time clinical judgement including analysis of information of US, artery-base CT, fluorescence image, liver anatomy and patient condition. The laparoscopic hepatectomy was performed with pringle vascular control.
Stage IV: the specimen information including tumor size and margin in vitro was recoded. The distance between surgical margin and enhanced liver were measured.
- Conditions
- Hepatic Carcinoma
- Being tested
- Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
- Keywords
- indocynide green, Image guide surgery, near infra-red laparoscopy, laparoscopic hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive StainingProcedure or surgery
The patients with single HCC which is planned to received laparoscopic hepatectomy were involved. Procedures were performed in conventional angiography room. The celiac trunk was catheterized and a microcatheter was advanced into segmental hepatic artery branches which supplied the HCC. The 5cc 0.125 mg/cc ICG was injected from super-selective hepatic artery in operative room. A Near-Infrared laparoscope was used to detect the fluorescent signal to assess the correspondence between arterial-based fluorescence demarcation and ultrasound-based surgical demarcation.
| Study group | Role | What they receive |
|---|---|---|
| super-selective hepatic artery ICG injection group | Experimental | single arm for feasibility study of intra-hepatic artery base fluorescent segmental demarcation Receives: Procedure: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent hepatic segment demarcation area
The surface size of fluorescent enhanced hepatic segment were measured as cm x cm .
Measured: intra-operative period
the rate of fluorescent demarcation corresponding to US guide resection area
The evaluation of the fluorescent hepatic surface which is included in the resected area or not
Measured: intra-operative period
The minimal distance between tumor and fluorescent margin
The distance between tumor edge and fluorescent parenchyma edge was measured as cm. This purpose was to evaluation the oncologic safety if the resection line is following the fluorescent margin
Measured: intra-operative period
The minimal surgical margin
The distance between tumor edge and resected parenchyma edge was measured as cm.
Measured: intra-operative period
surgical benefit rate of fluorescent image
If the fluorescent enhanced area is similar to resected parenchyma or the information of fluorescent image change the primary surgical plan, it was indicated benefit for surgery.
Measured: intra-operative period
Secondary outcomes (4)
Post operative complication
any complication related to surgery
Measured: one months after operation
Post operative angiography procedure complication
any complication related to angiography procedure
Measured: one months after operation
Post operative hospital stay
The day in hospital after operation
Measured: one months after operation
Post operative Mortality
any mortality related to surgery
Measured: any complication related to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start9 Jul 2018
- Primary completion6 Dec 2019
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hepatic CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study was the clinical feasibility study. Only selected single HCC patients was enrolled to study the feasibility of image guide surgery for laparoscopic hepatectomy
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Yin Liu, MD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266548
- Sponsor's protocol ID
- CGMH-20170147A3
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to special technique, data is unique and difficult to fit with other study
Publications
Diana M, Liu YY, Pop R, Kong SH, Legner A, Beaujeux R, Pessaux P, Soler L, Mutter D, Dallemagne B, Marescaux J. Superselective intra-arterial hepatic injection of indocyanine green (ICG) for fluorescence image-guided segmental positive staining: experimental proof of the concept. Surg Endosc. 2017 Mar;31(3):1451-1460. doi: 10.1007/s00464-016-5136-y. Epub 2016 Aug 5.
PubMed 27495341Ishizawa T, Gumbs AA, Kokudo N, Gayet B. Laparoscopic segmentectomy of the liver: from segment I to VIII. Ann Surg. 2012 Dec;256(6):959-64. doi: 10.1097/SLA.0b013e31825ffed3.
PubMed 22968066Ferrero A, Lo Tesoriere R, Russolillo N, Vigano L, Forchino F, Capussotti L. Ultrasound-guided laparoscopic liver resections. Surg Endosc. 2015 Apr;29(4):1002-5. doi: 10.1007/s00464-014-3762-9. Epub 2014 Aug 19.
PubMed 25135446Shindoh J, Seyama Y, Matsuda M, Miyata Y, Shida D, Maeshiro T, Miyamoto S, Inoue S, Umekita N. Continuous ultrasound navigation for safe and precise anatomic resection of the liver. Hepatogastroenterology. 2013 May;60(123):590-4. doi: 10.5754/hge12861.
PubMed 23282740Rethy A, Lango T, Marvik R. Laparoscopic ultrasound for hepatocellular carcinoma and colorectal liver metastasis: an overview. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):135-44. doi: 10.1097/SLE.0b013e31828a0b9a.
PubMed 23579506Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.
PubMed 2996162Gotoh K, Yamada T, Ishikawa O, Takahashi H, Eguchi H, Yano M, Ohigashi H, Tomita Y, Miyamoto Y, Imaoka S. A novel image-guided surgery of hepatocellular carcinoma by indocyanine green fluorescence imaging navigation. J Surg Oncol. 2009 Jul 1;100(1):75-9. doi: 10.1002/jso.21272.
PubMed 19301311Tanaka T, Takatsuki M, Hidaka M, Hara T, Muraoka I, Soyama A, Adachi T, Kuroki T, Eguchi S. Is a fluorescence navigation system with indocyanine green effective enough to detect liver malignancies? J Hepatobiliary Pancreat Sci. 2014 Mar;21(3):199-204. doi: 10.1002/jhbp.17. Epub 2013 Jul 1.
PubMed 23818301Aoki T, Yasuda D, Shimizu Y, Odaira M, Niiya T, Kusano T, Mitamura K, Hayashi K, Murai N, Koizumi T, Kato H, Enami Y, Miwa M, Kusano M. Image-guided liver mapping using fluorescence navigation system with indocyanine green for anatomical hepatic resection. World J Surg. 2008 Aug;32(8):1763-7. doi: 10.1007/s00268-008-9620-y.
PubMed 18543027Ishizawa T, Zuker NB, Kokudo N, Gayet B. Positive and negative staining of hepatic segments by use of fluorescent imaging techniques during laparoscopic hepatectomy. Arch Surg. 2012 Apr;147(4):393-4. doi: 10.1001/archsurg.2012.59. No abstract available.
PubMed 22508790Sakoda M, Ueno S, Iino S, Hiwatashi K, Minami K, Kawasaki Y, Kurahara H, Mataki Y, Maemura K, Uenosono Y, Shinchi H, Natsugoe S. Anatomical laparoscopic hepatectomy for hepatocellular carcinoma using indocyanine green fluorescence imaging. J Laparoendosc Adv Surg Tech A. 2014 Dec;24(12):878-82. doi: 10.1089/lap.2014.0243.
PubMed 25347551Li WF, Al-Taher M, Yu CY, Liu YW, Liu YY, Marescaux J, Cheng YF, Diana M, Wang CC. Super-Selective Intra-Arterial Indocyanine Green Administration for Near-Infrared Fluorescence-Based Positive Staining of Hepatic Segmentation: A Feasibility Study. Surg Innov. 2021 Dec;28(6):669-678. doi: 10.1177/1553350621996972. Epub 2021 Mar 31.
PubMed 33787401
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
- ClinicalTrials.gov ID
- NCT04266548
- Acronym / sponsor ID
- CGMH-20170147A3
- Conditions
- Hepatic Carcinoma
- Keywords
- indocynide green, Image guide surgery, near infra-red laparoscopy, laparoscopic hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- 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.
More and more laparoscopic hepatectomy were performed due to increasing experience, well designed instruments and energy device. But the localization of tumor and resection line design are still relative difficult comparing open approach due to limit space. Intraoperative liver segmentation can be obtained by ultrasound-guide intraportal injection of a fluorophore and illuminating with a Near-Infrared light source for positive staining and by intravenous injection after ligation of segmental vessels for negative staining .The ultrasound guide intraportal injection approach is challenging in the minimally-invasive setting. However hepatocelluar carcinoma(HCC) was supplied by hepatic artery mainly. The investigators aimed to evaluate the feasibility of arterial base positive staining for fluorescence liver segmentation in human by superselective intra-hepatic artery injection of Indocyanine Green (ICG) .
Detailed description
Materials and Methods
- Participants The present prospective, single-center, feasibility study of fluorescence demarcation of hepatic segment including HCC by means of direct super-selective intrahepatic artery ICG injection. Patients were enrolled according to the following criteria: single HCC, scheduled for laparoscopic hepatectomy for curative resection, age ranging from 20 to 85 years old, absence of proven or suspected allergies to iodine or ICG, absence of coagulopathy, absence of diseases contraindicating general anesthesia, and absence of pregnancy. All the bio-chemical test, cardiac echo , cardiac thalium test, ICG clearance test, Liver CT or MRI were obtained before operation
- Equipment Endovascular procedure was performed in the conventional angiography room and laparoscopic hepatecotmy was done in operating room at the Kaohsiung Chang Gung memorial hospital. Near infra-red fluorescence laparoscopy was used to acquire the fluorescence signal arising from the liver parenchyma after Indocyanine Green (ICG) injection.
- Procedures
- Celiac trunk angiography and super-selective hepatic angiography: A 4 Fr angiography sheath (Terumo Europe NV, Belgium) was placed under aseptic conditions in the right femoral artery, using the Seldinger technique. A 4 Fr Cobra-2 catheter (Terumo Europe NV, Belgium) was positioned at the origin of the celiac trunk. A selective celiac trunk digital subtraction angiographic (DSA) run was performed, after injection of a contrast medium (Visipaque 270, GE Healthcare; Buckinghamshire, United Kingdom), 28mL at a rate of 4mL/sec. A 2.7 French micro-catheter (Progreat™, Terumo Europe NV; Belgium) was used to super-selectively catheterize different hepatic segmental arteries supplying the target hepatic segment including HCC. In all cases, the position was controlled by performing DSA and angio computer tomography runs with selective micro-catheter injections. The micro-catheter was then perfused with saline and left in place until surgery. Then the patients were transferred to operative room while operative room available.
- Evaluation of hepatic segmental demarcation using NIR real-time imaging during laparoscopic hepatectomy:
The patients underwent a standard 5-port laparoscopic hepatectomy, which was performed by 2 experienced laparoscopic surgeons .
Stage I : the liver mobilization was performed for preparing the hepatectomy. The intraoperative ultrasound was used for localization of HCC. The resection line was defined as principle of laparoscopic hepatectomy such as surgical margin, surgical volume and etc. The pringle control device was prepared.
Stage II : Rea-time enhanced visualization of the hepatic segment which were supplied feeding artery was achieved by means of fluorescence imaging using a direct selective intrahepatic artery injection of a 5 mL bolus of ICG (DiagnoGreen®, Taiwan, ROC) at a concentration of 0.125mg/mL. The demarcation of enhanced hepatic segment were defined. The correspondence between the fluorescence margin and ultrasound(US) guide resection line were analized.
Stage III: The surgical resection line was chose by real time clinical judgement including analysis of information of US, artery-base CT, fluorescence image, liver anatomy and patient condition. The laparoscopic hepatectomy was performed with pringle vascular control.
Stage IV: the specimen information including tumor size and margin in vitro was recoded. The distance between surgical margin and enhanced liver were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was the clinical feasibility study. Only selected single HCC patients was enrolled to study the feasibility of image guide surgery for laparoscopic hepatectomy
| Arm | Type | Receives |
|---|---|---|
| super-selective hepatic artery ICG injection group | Experimental | Procedure: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Stainingsingle arm for feasibility study of intra-hepatic artery base fluorescent segmental demarcation |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single Hepatocellular carcinoma.
- plan of Laparoscopic hepatectomy.
- Age between 20 to 85 y/o.
Key exclusion criteria (5 listed)
- allergies to iodine or ICG
- Liver cirrhosis
- coagulopathy
- chronic kidney disease
- pregnancy
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 |
|---|---|---|
| Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive StainingThe patients with single HCC which is planned to received laparoscopic hepatectomy were involved. Procedures were performed in conventional angiography room. The celiac trunk was catheterized and a microcatheter was advanced into segmental hepatic artery branches which supplied the HCC. The 5cc 0.125 mg/cc ICG was injected from super-selective hepatic artery in operative room. A Near-Infrared laparoscope was used to detect the fluorescent signal to assess the correspondence between arterial-based fluorescence demarcation and ultrasound-based surgical demarcation. | Procedure or surgery | super-selective hepatic artery ICG injection group |
Primary outcome
Fluorescent hepatic segment demarcation area
Time frame: intra-operative period
The surface size of fluorescent enhanced hepatic segment were measured as cm x cm .
the rate of fluorescent demarcation corresponding to US guide resection area
Time frame: intra-operative period
The evaluation of the fluorescent hepatic surface which is included in the resected area or not
The minimal distance between tumor and fluorescent margin
Time frame: intra-operative period
The distance between tumor edge and fluorescent parenchyma edge was measured as cm. This purpose was to evaluation the oncologic safety if the resection line is following the fluorescent margin
The minimal surgical margin
Time frame: intra-operative period
The distance between tumor edge and resected parenchyma edge was measured as cm.
surgical benefit rate of fluorescent image
Time frame: intra-operative period
If the fluorescent enhanced area is similar to resected parenchyma or the information of fluorescent image change the primary surgical plan, it was indicated benefit for surgery.
4 secondary outcomes
Post operative complication
Time frame: one months after operation
Post operative angiography procedure complication
Time frame: one months after operation
Post operative hospital stay
Time frame: one months after operation
Post operative Mortality
Time frame: any complication related to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 27495341Diana M, Liu YY, Pop R, Kong SH, Legner A, Beaujeux R, Pessaux P, Soler L, Mutter D, Dallemagne B, Marescaux J. Superselective intra-arterial hepatic injection of indocyanine green (ICG) for fluorescence image-guided segmental positive staining: experimental proof of the concept. Surg Endosc. 2017 Mar;31(3):1451-1460. doi: 10.1007/s00464-016-5136-y. Epub 2016 Aug 5.
- Results publication: PubMed 22968066Ishizawa T, Gumbs AA, Kokudo N, Gayet B. Laparoscopic segmentectomy of the liver: from segment I to VIII. Ann Surg. 2012 Dec;256(6):959-64. doi: 10.1097/SLA.0b013e31825ffed3.
- Results publication: PubMed 25135446Ferrero A, Lo Tesoriere R, Russolillo N, Vigano L, Forchino F, Capussotti L. Ultrasound-guided laparoscopic liver resections. Surg Endosc. 2015 Apr;29(4):1002-5. doi: 10.1007/s00464-014-3762-9. Epub 2014 Aug 19.
- Results publication: PubMed 23282740Shindoh J, Seyama Y, Matsuda M, Miyata Y, Shida D, Maeshiro T, Miyamoto S, Inoue S, Umekita N. Continuous ultrasound navigation for safe and precise anatomic resection of the liver. Hepatogastroenterology. 2013 May;60(123):590-4. doi: 10.5754/hge12861.
- Results publication: PubMed 23579506Rethy A, Lango T, Marvik R. Laparoscopic ultrasound for hepatocellular carcinoma and colorectal liver metastasis: an overview. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):135-44. doi: 10.1097/SLE.0b013e31828a0b9a.
- Results publication: PubMed 2996162Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.
- Results publication: PubMed 19301311Gotoh K, Yamada T, Ishikawa O, Takahashi H, Eguchi H, Yano M, Ohigashi H, Tomita Y, Miyamoto Y, Imaoka S. A novel image-guided surgery of hepatocellular carcinoma by indocyanine green fluorescence imaging navigation. J Surg Oncol. 2009 Jul 1;100(1):75-9. doi: 10.1002/jso.21272.
- Results publication: PubMed 23818301Tanaka T, Takatsuki M, Hidaka M, Hara T, Muraoka I, Soyama A, Adachi T, Kuroki T, Eguchi S. Is a fluorescence navigation system with indocyanine green effective enough to detect liver malignancies? J Hepatobiliary Pancreat Sci. 2014 Mar;21(3):199-204. doi: 10.1002/jhbp.17. Epub 2013 Jul 1.
- Results publication: PubMed 18543027Aoki T, Yasuda D, Shimizu Y, Odaira M, Niiya T, Kusano T, Mitamura K, Hayashi K, Murai N, Koizumi T, Kato H, Enami Y, Miwa M, Kusano M. Image-guided liver mapping using fluorescence navigation system with indocyanine green for anatomical hepatic resection. World J Surg. 2008 Aug;32(8):1763-7. doi: 10.1007/s00268-008-9620-y.
- Results publication: PubMed 22508790Ishizawa T, Zuker NB, Kokudo N, Gayet B. Positive and negative staining of hepatic segments by use of fluorescent imaging techniques during laparoscopic hepatectomy. Arch Surg. 2012 Apr;147(4):393-4. doi: 10.1001/archsurg.2012.59. No abstract available.
- Results publication: PubMed 25347551Sakoda M, Ueno S, Iino S, Hiwatashi K, Minami K, Kawasaki Y, Kurahara H, Mataki Y, Maemura K, Uenosono Y, Shinchi H, Natsugoe S. Anatomical laparoscopic hepatectomy for hepatocellular carcinoma using indocyanine green fluorescence imaging. J Laparoendosc Adv Surg Tech A. 2014 Dec;24(12):878-82. doi: 10.1089/lap.2014.0243.
- Derived from this study: PubMed 33787401Li WF, Al-Taher M, Yu CY, Liu YW, Liu YY, Marescaux J, Cheng YF, Diana M, Wang CC. Super-Selective Intra-Arterial Indocyanine Green Administration for Near-Infrared Fluorescence-Based Positive Staining of Hepatic Segmentation: A Feasibility Study. Surg Innov. 2021 Dec;28(6):669-678. doi: 10.1177/1553350621996972. Epub 2021 Mar 31.
- Individual participant dataSharing planned: No. due to special technique, data is unique and difficult to fit with other study
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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.
Yu-Yin Liu, MD study director
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 Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining in people with Hepatic Carcinoma, 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 3 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: finished, as of the sponsor's last update on 12 Feb 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescent hepatic segment demarcation area (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 NCT04266548, which also lists 12 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 12 Feb 2020.