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Effectivity and Safety of Endoscopic Ultrasonography-guided Laser Ablation for Refractory Neoplasms

NCT ID: NCT02816944

Last Updated: 2016-06-30

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

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 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.

Detailed Description

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Conditions

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Refractory Neoplasms

Keywords

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Endoscopic ultrasonography Laser ablation

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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EUS-guided laser ablation for refractory neoplasms

Group Type EXPERIMENTAL

EUS-guided laser ablation for refractory neoplasms

Intervention Type PROCEDURE

Interventions

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EUS-guided laser ablation for refractory neoplasms

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients with severe cardiopulmonary disease, intolerant endoscopy and anesthesia, upper gastrointestinal bleeding in shock, corrosive esophagitis and acute gastritis.
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

Phone: +86 18857127666

Email: [email protected]

Guo Tian, Master

Role: CONTACT

Phone: +86 13600529967

Email: [email protected]

Facility Contacts

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Tian'an Jiang, Phd

Role: primary

Guo Tian, Master

Role: backup

References

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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.

Reference Type RESULT
PMID: 25254586 (View on PubMed)

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.

Reference Type RESULT
PMID: 21030019 (View on PubMed)

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.

Reference Type RESULT
PMID: 23680175 (View on PubMed)

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.

Reference Type RESULT
PMID: 20541187 (View on PubMed)

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.

Reference Type RESULT
PMID: 22632957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36415178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27958384 (View on PubMed)

Other Identifiers

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LA-004

Identifier Type: -

Identifier Source: org_study_id