NCT02816944

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of endoscopic ultrasonography (EUS) guided laser ablation liver, pancreas, 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
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 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

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 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

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

June 23, 2016

Last Update Submit

June 29, 2016

Conditions

Refractory Neoplasms

Keywords

Endoscopic ultrasonographyLaser ablation

Outcome Measures

Primary Outcomes (1)

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

    up to 24 months

Study Arms (1)

EUS-guided laser ablation for refractory neoplasms

EXPERIMENTAL
Procedure: EUS-guided laser ablation for refractory neoplasms

Interventions

EUS-guided laser ablation for refractory neoplasmsPROCEDURE
EUS-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 refractory neoplasms including small hepatocellular carcinoma adjacent to the gastrointestinal tract, pancreatic neuroendocrine tumor, retroperitoneal tumor with 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 severe cardiopulmonary disease, intolerant endoscopy and anesthesia, upper gastrointestinal bleeding in shock, corrosive esophagitis and acute gastritis.

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 (7)

  • Di Matteo F, Picconi F, Martino M, Pandolfi M, Pacella CM, Schena E, Costamagna G. Endoscopic ultrasound-guided Nd:YAG laser ablation of recurrent pancreatic neuroendocrine tumor: a promising revolution? Endoscopy. 2014;46 Suppl 1 UCTN:E380-1. doi: 10.1055/s-0034-1377376. Epub 2014 Sep 25. No abstract available.

    PMID: 25254586RESULT

  • 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: 21030019RESULT

  • Di Matteo F, Martino M, Rea R, Pandolfi M, Panzera F, Stigliano E, Schena E, Saccomandi P, Silvestri S, Pacella CM, Breschi L, Perrone G, Coppola R, Costamagna G. US-guided application of Nd:YAG laser in porcine pancreatic tissue: an ex vivo study and numerical simulation. Gastrointest Endosc. 2013 Nov;78(5):750-5. doi: 10.1016/j.gie.2013.04.178. Epub 2013 May 13.

    PMID: 23680175RESULT

  • Di Matteo F, Martino M, Rea R, Pandolfi M, Rabitti C, Masselli GM, Silvestri S, Pacella CM, Papini E, Panzera F, Valeri S, Coppola R, Costamagna G. EUS-guided Nd:YAG laser ablation of normal pancreatic tissue: a pilot study in a pig model. Gastrointest Endosc. 2010 Aug;72(2):358-63. doi: 10.1016/j.gie.2010.02.027. Epub 2010 Jun 11.

    PMID: 20541187RESULT

  • Yoon WJ, Brugge WR. Endoscopic ultrasonography-guided tumor ablation. Gastrointest Endosc Clin N Am. 2012 Apr;22(2):359-69, xi. doi: 10.1016/j.giec.2012.04.017.

    PMID: 22632957RESULT

  • Xu M, Xu D, Deng Z, Tian G, Jiang T. Long-term outcomes of endoscopic ultrasound-guided laser ablation for liver tumors in the caudate lobe: 5 years of experience. Scand J Gastroenterol. 2023 May;58(5):558-564. doi: 10.1080/00365521.2022.2148833. Epub 2022 Nov 22.

    PMID: 36415178DERIVED

  • 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: 27958384DERIVED

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 23, 2016

First Posted

June 29, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations

CN(1)