Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography

Hepatocellular Carcinoma Clinical Trial

Official title:

Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304572
• Other study ID #: MDCT angiography HCC
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography acquired before Trans-arterial Chemo-embolization (TACE) in detecting Hepato-cellular carcinoma feeding vessels compared to DSA angiography acquired during TACE.

Description:

Hepatocellular carcinoma (HCC) represents the sixth most common cancer worldwide. Trans-arterial chemoembolization (TACE) is a palliative treatment for patients with HCC who are not candidates for transplantation, surgical resection, or loco-regional ablation. This minimally invasive procedure allows delivery of a high concentration of particles and/or chemotherapeutic agents into the liver, causing ischemic cell death and permitting local delivery of high concentrations of chemotherapeutic drug. Selective administration of chemo-embolic material to the tumor is desired, where possible, to increase the effectiveness of treatment to the tumor and minimize injury to surrounding liver tissue.

Tumor detection and assessment of the tumor-feeding vessel(s) are important for an effective treatment, while limiting non-target embolization. Usually, selection of the tumor-feeding vessels during TACE has been guided by 2D digital subtraction angiography (DSA). However; this method has a disadvantage of occasional misinterpretation of tumor-feeding vessels due to superimposition of vessels. To prevent such misinterpretation, multiple selective injections and oblique projections are performed during TACE with consequent increase in procedure time, volume of injected contrast material, and radiation doses.

A relatively new approach using three-dimensional (3D) cone-beam CT angiography during TACE is reported to be extremely helpful, especially in cases of complex hepatic arterial anatomy. However, the time required for processing and evaluating this 3D angiography images may discourage its routine use by intervention radiologists because it requires either a sterile remote control for in-room review or the operator exit from the angiographic room to access a workstation. A new automatic specifically designed softwares has been developed for detection of feeding vessels after Cone beam CT, but these softwares are not widely available.

Multiphasic contrast enhanced CT is one of the recommended imaging tools for diagnosis of HCC and is routinely done before TACE. There are few reports on the application of Multi-Detector CT angiography for detection of HCC feeding vessels before TACE.

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography for assessment of tumor-feeding vessel in patients planned for TACE compared to DSA angiography acquired during TACE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with HCC not suitable for resection, liver transplantation, or percutaneous ablation.

• CHILD class A/B cirrhosis.

• patent main portal vein.

• less than 50% involvement of the liver by the tumor.

• no vascular invasion or extrahepatic spread of the HCC.

• normal renal functions.

• bilirubin level < 2 mg/dl .

Exclusion Criteria:

• Pre-TACE Multi-Detector CT raw DICOM images could not be obtained for 3D processing

• patients with only available Pre-TACE MRI images

• Failed TACE due to technical factors

• Non-selective TACE technique

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Multi-Detector CT angiography
Multiphasic CT within 4 weeks interval prior to TACE will be done including non-enhanced, arterial, portal and venous phases using IV bolus injection of a 75-100-mLiodinated contrast material iopamidol at a rate of 3.0 mL/s. The images of arterial phase will be transferred to workstation to produce 3D angiographic reconstruction images .

Procedure:
• Trans-arterial chemoembolization and DSA
Percutaneous arterial access is achieved through the common femoral artery (19 G needle) under local anesthesia with placement of a 5-Fr sheath. A 5-Fr Cobra (C2) or sidewinder (SIM1) catheter was used for catheterizing the coeliac trunk and SMA. Then celiac and superior mesenteric angiography was done by injecting 24 mL of iopamidol using forced manual injection method or using a pump at a rate of 6 mL/s according to the operator preferences.Then a microcatheter was used for selective and super-selective access of the hepatic arteries. The micro-catheter was placed in the feeding artery as close as possible to the tumor.The chemotherapeutic drugs (Doxorubicin 50 mg) solved within 5 ml of iodinated non-ionic contrast media and then mixed with 10 ml of iodized oil (lipiodol) will be delivered through the feeding hepatic artery and then embolized using Poly-vinyl Alcohol (PVA) particles.

Locations

Country	Name	City	State
Egypt	Assiut Universtiy Hospital; Alrajhy Liver institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

Brown DB, Geschwind JF, Soulen MC, Millward SF, Sacks D. Society of Interventional Radiology position statement on chemoembolization of hepatic malignancies. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S317-23. doi: 10.1016/j.jvir.2009.04.015. No abstract available. — View Citation

Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available. — View Citation

Chiaradia M, Izamis ML, Radaelli A, Prevoo W, Maleux G, Schlachter T, Mayer J, Luciani A, Kobeiter H, Tacher V. Sensitivity and Reproducibility of Automated Feeding Artery Detection Software during Transarterial Chemoembolization of Hepatocellular Carcinoma. J Vasc Interv Radiol. 2018 Mar;29(3):425-431. doi: 10.1016/j.jvir.2017.10.025. Epub 2018 Feb 3. — View Citation

Deschamps F, Solomon SB, Thornton RH, Rao P, Hakime A, Kuoch V, de Baere T. Computed analysis of three-dimensional cone-beam computed tomography angiography for determination of tumor-feeding vessels during chemoembolization of liver tumor: a pilot study. Cardiovasc Intervent Radiol. 2010 Dec;33(6):1235-42. doi: 10.1007/s00270-010-9846-6. — View Citation

Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5. — View Citation

Huang JH, Fan WJ, Li CJ, Gu YK, Zhang L, Gao F, Lu LW, Li WQ. Application of multislice spiral CT angiography on transcatheter arterial chemoembolization for hepatocellular carcinoma. Ai Zheng. 2009 Feb;28(2):159-63. Epub 2009 Feb 15. — View Citation

Kakeda S, Korogi Y, Ohnari N, Moriya J, Oda N, Nishino K, Miyamoto W. Usefulness of cone-beam volume CT with flat panel detectors in conjunction with catheter angiography for transcatheter arterial embolization. J Vasc Interv Radiol. 2007 Dec;18(12):1508-16. doi: 10.1016/j.jvir.2007.08.003. — View Citation

Kim I, Kim DJ, Kim KA, Yoon SW, Lee JT. Feasibility of MDCT angiography for determination of tumor-feeding vessels in chemoembolization of hepatocellular carcinoma. J Comput Assist Tomogr. 2014 Sep-Oct;38(5):742-6. doi: 10.1097/RCT.0000000000000103. — View Citation

Liapi E, Hong K, Georgiades CS, Geschwind JF. Three-dimensional rotational angiography: introduction of an adjunctive tool for successful transarterial chemoembolization. J Vasc Interv Radiol. 2005 Sep;16(9):1241-5. doi: 10.1097/01.RVI.0000174283.03032.8E. — View Citation

Marelli L, Stigliano R, Triantos C, Senzolo M, Cholongitas E, Davies N, Tibballs J, Meyer T, Patch DW, Burroughs AK. Transarterial therapy for hepatocellular carcinoma: which technique is more effective? A systematic review of cohort and randomized studies. Cardiovasc Intervent Radiol. 2007 Jan-Feb;30(1):6-25. doi: 10.1007/s00270-006-0062-3. — View Citation

Miyayama S, Yamashiro M, Okuda M, Yoshie Y, Sugimori N, Igarashi S, Nakashima Y, Matsui O. Usefulness of cone-beam computed tomography during ultraselective transcatheter arterial chemoembolization for small hepatocellular carcinomas that cannot be demonstrated on angiography. Cardiovasc Intervent Radiol. 2009 Mar;32(2):255-64. doi: 10.1007/s00270-008-9468-4. Epub 2008 Dec 9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feeding vessels detectability	The observers will evaluate DSA images of the celiac, superior mesenteric artery (SMA), common hepatic artery (CHA), right or left hepatic arteries obtained during TACE and record possible feeding arteries. Observers will be blind to additional angio-grams obtained during TACE i.e selective DSA images of the segmental arteries and feeding arteries. observers will then evaluate the CT 3D images and record possible feeding arteries. The ''ground truth'' (GT) will be the gold standard tool and is obtained after completing the above mentioned analyses by allowing the observers to evaluate by consensus pre-embolization CT 2D and 3D images, all acquired DSA images during TACE , and post-lipiodol injection CT images if available. GT was used to define true-positive, false-positive, false-negative and true negative feeding vessels.	Baseline
Secondary	inter-observer agreement	Interobserver variability was assessed using kappa statistics. Interobserver agreement was defined as excellent, fair to good, and poor by kappa values of >0.75, 0.40-0.75, and <0.40, respectively. for each technique.	Baseline