A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of EUS-LA for Liver Cancer

NCT05709886 | Unknown

• 1 other identifier: eusLAliver
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound-guided laser ablation by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.

Conditions

Liver Cancer

Keywords

liver cancer; laser; ablation; endoscopic ultrasound

Outcome Measures

Primary Outcomes (2)

• Complete ablation rate

  Defined as the absence of any contrast uptake within or at the periphery of the ablative zone. One month after either one session or multiple LA sessions, CTA was confirmed by contrast-enhanced MRI.

  1 month

• Effectiveness analysis

  The effective rate of EUS-LA by LaserPro Diode Laser System for liver cancer was evaluated by mRECIST criteria.

  6 months

Secondary Outcomes (10)

• Technical success rate

  1 month

• Major complication rate

  6 months

• Partial response rate

  6 months

• Secondary ablation rate

  6 months

• Progression-free survival (PFS)

  6 months

Study Arms (1)

EUS-LA by LaserPro Diode Laser System

EXPERIMENTAL

This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.

Device: EUS-LA by LaserPro Diode Laser System

Interventions

EUS-LA by LaserPro Diode Laser System DEVICE

This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.

EUS-LA by LaserPro Diode Laser System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
• Liver tumors within the scope of EUS scanning.
• Single tumor≤ 3cm in diameter and the number of visible tumor were no more than 3. According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
• Liver function: Child-Pugh A or B.
• Age: 18-75 years old, regardless of gender.
• Patients signed informed consent to participate in the trial.

You may not qualify if:

• Contraindication for EUS or the target tumor were beyond the scope of EUS scanning.
• Liver function: Child-pugh C, those could not improve after liver protective treatment.
• Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding; platelet count less than 50×109/L, prothrombin time more than 30s or prothrombin activity less than 40%.
• Severe failure of major organs such as kidney, heart, lung and brain.
• Uncontrolled infection in any organ, especially inflammation of the biliary system.
• Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Yiwu Central Hospital: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (13)

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  PMID: 29031662 BACKGROUND

• Hong K, Georgiades CS, Geschwind JF. Technology insight: Image-guided therapies for hepatocellular carcinoma--intra-arterial and ablative techniques. Nat Clin Pract Oncol. 2006 Jun;3(6):315-24. doi: 10.1038/ncponc0512.

  PMID: 16757969 BACKGROUND

• Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.

  PMID: 30970190 BACKGROUND

• Petrowsky H, Fritsch R, Guckenberger M, De Oliveira ML, Dutkowski P, Clavien PA. Modern therapeutic approaches for the treatment of malignant liver tumours. Nat Rev Gastroenterol Hepatol. 2020 Dec;17(12):755-772. doi: 10.1038/s41575-020-0314-8. Epub 2020 Jul 17.

  PMID: 32681074 BACKGROUND

• Pacella CM, Francica G, Di Lascio FM, Arienti V, Antico E, Caspani B, Magnolfi F, Megna AS, Pretolani S, Regine R, Sponza M, Stasi R. Long-term outcome of cirrhotic patients with early hepatocellular carcinoma treated with ultrasound-guided percutaneous laser ablation: a retrospective analysis. J Clin Oncol. 2009 Jun 1;27(16):2615-21. doi: 10.1200/JCO.2008.19.0082. Epub 2009 Mar 30.

  PMID: 19332729 BACKGROUND

• Arienti V, Pretolani S, Pacella CM, Magnolfi F, Caspani B, Francica G, Megna AS, Regine R, Sponza M, Antico E, Di Lascio FM. Complications of laser ablation for hepatocellular carcinoma: a multicenter study. Radiology. 2008 Mar;246(3):947-55. doi: 10.1148/radiol.2463070390. Epub 2008 Jan 14.

  PMID: 18195382 BACKGROUND

• Di Costanzo GG, Tortora R, D'Adamo G, De Luca M, Lampasi F, Addario L, Galeota Lanza A, Picciotto FP, Tartaglione MT, Cordone G, Imparato M, Mattera S, Pacella CM. Radiofrequency ablation versus laser ablation for the treatment of small hepatocellular carcinoma in cirrhosis: a randomized trial. J Gastroenterol Hepatol. 2015 Mar;30(3):559-65. doi: 10.1111/jgh.12791.

  PMID: 25251043 BACKGROUND

• Di Costanzo GG, Francica G, Pacella CM. Laser ablation for small hepatocellular carcinoma: State of the art and future perspectives. World J Hepatol. 2014 Oct 27;6(10):704-15. doi: 10.4254/wjh.v6.i10.704.

  PMID: 25349642 BACKGROUND

• Pacella CM, Francica G, Di Costanzo GG. Laser ablation for small hepatocellular carcinoma. Radiol Res Pract. 2011;2011:595627. doi: 10.1155/2011/595627. Epub 2011 Dec 4.

  PMID: 22191028 BACKGROUND

• Chai W, Zhao Q, Song H, Cheng C, Tian G, Jiang T. Treatment response and preliminary efficacy of hepatic tumour laser ablation under the guidance of percutaneous and endoscopic ultrasonography. World J Surg Oncol. 2019 Aug 5;17(1):133. doi: 10.1186/s12957-019-1677-6.

  PMID: 31383020 BACKGROUND

• Di Matteo F, Grasso R, Pacella CM, Martino M, Pandolfi M, Rea R, Luppi G, Silvestri S, Zardi E, Costamagna G. EUS-guided Nd:YAG laser ablation of a hepatocellular carcinoma in the caudate lobe. Gastrointest Endosc. 2011 Mar;73(3):632-6. doi: 10.1016/j.gie.2010.08.019. Epub 2010 Oct 27. No abstract available.

  PMID: 21030019 BACKGROUND

• Jiang TA, Deng Z, Tian G, Zhao QY, Wang WL. Efficacy and safety of endoscopic ultrasonography-guided interventional treatment for refractory malignant left-sided liver tumors: a case series of 26 patients. Sci Rep. 2016 Dec 13;6:36098. doi: 10.1038/srep36098.

  PMID: 27958384 BACKGROUND

• Jiang T, Tian G, Bao H, Chen F, Deng Z, Li J, Chai W. EUS dating with laser ablation against the caudate lobe or left liver tumors: a win-win proposition? Cancer Biol Ther. 2018 Mar 4;19(3):145-152. doi: 10.1080/15384047.2017.1414760. Epub 2018 Jan 25.

  PMID: 29303406 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Tian'an Jiang, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian'an Jiang, PhD

CONTACT

86-18857127666; tiananjiang@zju.edu.cn

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: To evaluate whether the LaserPro Diode Laser System under the guidance of EUS can achieve the safety and effectiveness of local ablation for liver cancer.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 2, 2023
• Study Start: February 28, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: February 14, 2023

Record last verified: 2022-12

Locations

CN (1)