NCT02822053

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US) -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

June 20, 2016

Last Update Submit

July 1, 2016

Conditions

Refractory Neoplasms

Keywords

Ultrasonography-guided Laser Ablation

Outcome Measures

Primary Outcomes (1)

  • 100 patients of refractory neoplasms with image-guided laser ablation-related effectivity as assessed by MRI

    up to 24 months

Study Arms (1)

US-guided laser ablation for refractory neoplasms

EXPERIMENTAL

The investigators used percutaneously US-guided laser ablation for patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Child-Pugh A/B, PLT ≥ 50\*10E9/L and PT ≤ 20s. Then the investigators estimated the safety and efficacy of this treatment through follow-up of US/CEUS/CT/MRI and the tumor markers every three months.

Procedure: US-guided laser ablation for refractory neoplasms

Interventions

US-guided laser ablation for refractory neoplasmsPROCEDURE
US-guided laser ablation for refractory neoplasms

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter),
  • Patients with Child-Pugh A/B,
  • Patients with PLT ≥ 50\*10E9/L and PT ≤ 20s.

You may not qualify if:

  • Patients with blood coagulation dysfunction, ChildPugh ≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (6)

  • Francica G, Petrolati A, Di Stasio E, Pacella S, Stasi R, Pacella CM. Influence of ablative margin on local tumor progression and survival in patients with HCC </=4 cm after laser ablation. Acta Radiol. 2012 May 1;53(4):394-400. doi: 10.1258/ar.2012.110471. Epub 2012 Mar 5.

    PMID: 22393158RESULT

  • Wu X, Zhou P, Ma S, Tian S, Deng J, Zhao Y. [Ultrasound-guided laser thermal ablation for treatment of small liver cancer at high-risk sites]. Nan Fang Yi Ke Da Xue Xue Bao. 2016 Jan;36(1):120-5. Chinese.

    PMID: 26806751RESULT

  • Di Costanzo GG, D'Adamo G, Tortora R, Zanfardino F, Mattera S, Francica G, Pacella CM. A novel needle guide system to perform percutaneous laser ablation of liver tumors using the multifiber technique. Acta Radiol. 2013 Oct;54(8):876-81. doi: 10.1177/0284185113489825. Epub 2013 May 23.

    PMID: 23761559RESULT

  • Zou X, Liu Q, Zhou X, He G, Yu M, Han Z, Meng X, Su H. Ultrasound-guided percutaneous laser and ethanol ablation of rabbit VX2 liver tumors. Acta Radiol. 2013 Mar 1;54(2):181-7. doi: 10.1258/ar.2012.110723.

    PMID: 23482351RESULT

  • Clements LW, Collins JA, Weis JA, Simpson AL, Adams LB, Jarnagin WR, Miga MI. Evaluation of model-based deformation correction in image-guided liver surgery via tracked intraoperative ultrasound. J Med Imaging (Bellingham). 2016 Jan;3(1):015003. doi: 10.1117/1.JMI.3.1.015003. Epub 2016 Mar 23.

    PMID: 27081664RESULT

  • Jiang T, Deng Z, Tian G, Chen F, Bao H, Li J, Wang W. Percutaneous laser ablation: a new contribution to unresectable high-risk metastatic retroperitoneal lesions? Oncotarget. 2017 Jan 10;8(2):2413-2422. doi: 10.18632/oncotarget.13897.

    PMID: 27974691DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Tian'an Jiang, Phd

CONTACT

+86 18857127666tiananjiang@126.com

Guo Tian, Master

CONTACT

+86 13600529967871035504@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 4, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 4, 2016

Record last verified: 2016-06

Locations

CN(1)