Effectivity and Safety of Ultrasound-guided Percutaneously Laser Ablation for Refractory Neoplasms

NCT ID: NCT02822053

Last Updated: 2016-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Refractory Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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US-guided laser ablation for refractory neoplasms

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.

Group Type EXPERIMENTAL

US-guided laser ablation for refractory neoplasms

Intervention Type PROCEDURE

Interventions

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US-guided laser ablation for refractory neoplasms

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tian'an Jiang, Phd

Role: CONTACT

+86 18857127666

Guo Tian, Master

Role: CONTACT

+86 13600529967

Facility Contacts

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Tian'an Jiang, Phd

Role: primary

+86 18857127666

Guo Tian, Master

Role: backup

+86 13600529967

References

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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.

Reference Type RESULT
PMID: 22393158 (View on PubMed)

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.

Reference Type RESULT
PMID: 26806751 (View on PubMed)

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.

Reference Type RESULT
PMID: 23761559 (View on PubMed)

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.

Reference Type RESULT
PMID: 23482351 (View on PubMed)

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.

Reference Type RESULT
PMID: 27081664 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27974691 (View on PubMed)

Other Identifiers

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LA-002

Identifier Type: -

Identifier Source: org_study_id

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