Arterial Base Fluorescence Segmental Positive Staining

NCT04266548 | Completed

• 1 other identifier: CGMH-20170147A3
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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) .

Conditions

Hepatic Carcinoma

Keywords

indocynide green; Image guide surgery; near infra-red laparoscopy; laparoscopic hepatectomy

Outcome Measures

Primary Outcomes (5)

• Fluorescent hepatic segment demarcation area

  The surface size of fluorescent enhanced hepatic segment were measured as cm x cm .

  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

  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

  intra-operative period

• The minimal surgical margin

  The distance between tumor edge and resected parenchyma edge was measured as cm.

  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.

  intra-operative period

Secondary Outcomes (4)

• Post operative complication

  one months after operation

• Post operative angiography procedure complication

  one months after operation

• Post operative hospital stay

  one months after operation

• Post operative Mortality

  any complication related to surgery

Study Arms (1)

super-selective hepatic artery ICG injection group

EXPERIMENTAL

single arm for feasibility study of intra-hepatic artery base fluorescent segmental demarcation

Procedure: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining

Interventions

Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining PROCEDURE

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.

super-selective hepatic artery ICG injection group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single Hepatocellular carcinoma.
• plan of Laparoscopic hepatectomy.
• Age between 20 to 85 y/o.

You may not qualify if:

• allergies to iodine or ICG
• Liver cirrhosis
• coagulopathy
• chronic kidney disease
• pregnancy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Niaosong, Kaohsiung, 833, Taiwan

Location

Related Publications (12)

• 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.

  PMID: 27495341 BACKGROUND

• Ishizawa 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.

  PMID: 22968066 RESULT

• Ferrero 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.

  PMID: 25135446 RESULT

• Shindoh 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.

  PMID: 23282740 RESULT

• Rethy 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.

  PMID: 23579506 RESULT

• Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.

  PMID: 2996162 RESULT

• Gotoh 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.

  PMID: 19301311 RESULT

• Tanaka 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.

  PMID: 23818301 RESULT

• Aoki 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.

  PMID: 18543027 RESULT

• Ishizawa 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.

  PMID: 22508790 RESULT

• Sakoda 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.

  PMID: 25347551 RESULT

• Li 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.

  PMID: 33787401 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yu-Yin Liu, MD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 12, 2020
• Study Start: July 9, 2018
• Primary Completion: December 6, 2019
• Study Completion: January 6, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)