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Pre-planning Mathematical Models in EUS-guided Laser Ablation of Pancreatic Lesions

NCT05549960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-03

No results posted yet for this study

Summary

Pancreatic ductal adenocarcinoma (PDAC) is the fourth cause of cancer death in Western countries. More than 50% of the patients with PDAC has a local advanced or metastatic disease at the time of the diagnosis. There is a growing interest in the investigation of novel and alternative therapeutic strategies which could be used in synergy with radiotherapy and chemotherapy. These methods include echoendoscopic (EUS) guided locoregional ablation to reduce the tumoral mass.

The most studied technique is the radiofrequency ablation (RFA). Another interesting technique involves the use of the laser source at a wavelength of 1064 nm. Among all the ablative methods, LA is the only one that allows the use of a thinner needle. These features make LA a suitable option for treating focal lesions in high-risk areas or in hard-to-reach locations. A previous study demonstrated the feasibility of this technique in pancreatic solid lesions.

In order to perform a study aimed at the complete treatment of the lesion, it is necessary to identify the laser parameters which are specific to the size and location of the lesion.

The present protocol presents a prospective interventional study aimed at the analysis and applicability of predictive mathematical models for the calculation of laser settings in the ablation of pancreatic lesion by means of a EUS-guided LA.

Conditions

  • Pancreatic Neoplasms

Interventions

DEVICE

The medical device used in this study is a 980 nm wavelength diode laser with maximum output of 30 W (EUFOTON Laser Spectrum).

EUS will be performed with a FUJIFILM EG- 580UT linear endoscope. LA will be performed with a 980 nm laser light (EUFOTON Laser Spectrum) guided by a 300 μm optical fiber (EUFOTON). AN EUS-21 gauge needle (Boston Scientific Expect Slimline) will be used for the optical fiber placement. The protrusion of the fiber end from the needle tip should be 5 mm. After the correct placement of the fiber inside the tumor, the ablation treatment can start. Once inside the lesion, the needle will be slightly retracted, and the fiber will be gently pushed out of the needle tip by a length of 5 mm. The fiber will be placed at the top of the lesion, and the laser will be turned on. The laser settings estimated by the mathematical model will be used. The total number of ablations will depend on the radiological characteristics of the lesion and location. Special attention must be paid to have 1 cm between the fiber tip, the walls of the main vessels, and any metal stents that may be present.

Sponsors & Collaborators

  • Politecnico di Milano

    collaborator OTHER

  • Campus Bio-Medico University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-11-01
Completion
2023-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549960 on ClinicalTrials.gov