Effectivity and Safety of Endoscopic Ultrasonography-guid... | NCT02816944

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

NCT02816944

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Unknown status

Last Update Posted

Jun 30, 2016Estimated

Enrollment

80Estimated

Phase

Phase 1Phase 2

Conditions

Refractory Neoplasms

Interventions

EUS-guided laser ablation for refractory neoplasms

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Jun 23, 2016

First Submission Date that Met QC Criteria

Jun 28, 2016

First Posted Date

Jun 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2016

Last Update Posted Date

Jun 30, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUS-guided laser ablation for refractory neoplasms	Experimental		Procedure: EUS-guided laser ablation for refractory neoplasms

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS-guided laser ablation for refractory neoplasms	Procedure		EUS-guided laser ablation for refractory neoplasms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
80 patients of refractory neoplasms with EUS-guided laser ablation-related effectivity as assessed by MRI		up to 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tian'an Jiang, Phd	Contact	+86 18857127666		tiananjiang@126.com
Guo Tian, Master	Contact	+86 13600529967		871035504@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310003	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25254586	Result	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.
21030019	Result