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

NCT05549960 | Unknown

• 1 other identifier: LA-EUS MOD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endoscopic ultrasound; Local ablation; Laser Fiber; mathematical model

Outcome Measures

Primary Outcomes (1)

• Feasibility of pre-planned laser setting in lesion ablation

  Evaluate the applicability of mathematical models in predicting the laser settings estimation (energy = power x time) for LA EUS-guided of pancreatic lesions in order to obtain the major volume of ablation with less adverse events. The volume ablation obtained, will be calculated with CT/MRI.

  1,3,6 months

Secondary Outcomes (2)

• Progression free survival

  6 months

• Rate of resectability

  3 months

Study Arms (1)

pancreatic lesions

OTHER

Individuals with a histological diagnosis of locally advanced or metastatic (stage III or IV) pancreatic adenocarcinoma, functioning or non-functioning neuroendocrine tumor, pancreatic metastasis from inoperable renal cell carcinoma, or in affected patients not prone to treatment.

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

Interventions

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

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.

pancreatic lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of pancreatic ductal adenocarcinoma (stage III or IV);
• Inoperable neuroendocrine tumor;
• Pancreatic metastasis from renal clear cell cancer;
• Stable situation or progression after chemotherapeutic treatment;
• Age \>18 years;
• Acquisition of signed Informed Consent;
• Performance status 0-1-2 (ECOG).

You may not qualify if:

• Absolute contraindications to general anaesthesia or deep sedation;
• Absence of suitable ultrasound acoustic window for the procedure;
• Known bleeding disorders that cannot be sufficiently corrected with clotting factors or fresh frozen plasma (FFP);
• Use of anticoagulants that cannot be discontinued;
• International normalized ratio (INR) \>1.5 or platelet count \<50,000;
• Pregnancy or lactation;
• Inability to sign informed consent;
• Other concomitant neoplastic diseases.

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Serena Stigliano

Rome, ROMA, 00191, Italy

RECRUITING

Related Publications (16)

• Lakhtakia S, Seo DW. Endoscopic ultrasonography-guided tumor ablation. Dig Endosc. 2017 May;29(4):486-494. doi: 10.1111/den.12833. Epub 2017 Mar 16.

  PMID: 28171697 BACKGROUND

• Han J, Chang KJ. Endoscopic Ultrasound-Guided Direct Intervention for Solid Pancreatic Tumors. Clin Endosc. 2017 Mar;50(2):126-137. doi: 10.5946/ce.2017.034. Epub 2017 Mar 30.

  PMID: 28391669 BACKGROUND

• Ruarus A, Vroomen L, Puijk R, Scheffer H, Meijerink M. Locally Advanced Pancreatic Cancer: A Review of Local Ablative Therapies. Cancers (Basel). 2018 Jan 10;10(1):16. doi: 10.3390/cancers10010016.

  PMID: 29320420 BACKGROUND

• Girelli R, Frigerio I, Salvia R, Barbi E, Tinazzi Martini P, Bassi C. Feasibility and safety of radiofrequency ablation for locally advanced pancreatic cancer. Br J Surg. 2010 Feb;97(2):220-5. doi: 10.1002/bjs.6800.

  PMID: 20069610 BACKGROUND

• Girelli R, Frigerio I, Giardino A, Regi P, Gobbo S, Malleo G, Salvia R, Bassi C. Results of 100 pancreatic radiofrequency ablations in the context of a multimodal strategy for stage III ductal adenocarcinoma. Langenbecks Arch Surg. 2013 Jan;398(1):63-9. doi: 10.1007/s00423-012-1011-z. Epub 2012 Sep 29.

  PMID: 23053459 BACKGROUND

• Song TJ, Seo DW, Lakhtakia S, Reddy N, Oh DW, Park DH, Lee SS, Lee SK, Kim MH. Initial experience of EUS-guided radiofrequency ablation of unresectable pancreatic cancer. Gastrointest Endosc. 2016 Feb;83(2):440-3. doi: 10.1016/j.gie.2015.08.048. Epub 2015 Sep 4.

  PMID: 26344883 BACKGROUND

• Scopelliti F, Pea A, Conigliaro R, Butturini G, Frigerio I, Regi P, Giardino A, Bertani H, Paini M, Pederzoli P, Girelli R. Technique, safety, and feasibility of EUS-guided radiofrequency ablation in unresectable pancreatic cancer. Surg Endosc. 2018 Sep;32(9):4022-4028. doi: 10.1007/s00464-018-6217-x. Epub 2018 May 15.

  PMID: 29766302 BACKGROUND

• Crino SF, D'Onofrio M, Bernardoni L, Frulloni L, Iannelli M, Malleo G, Paiella S, Larghi A, Gabbrielli A. EUS-guided Radiofrequency Ablation (EUS-RFA) of Solid Pancreatic Neoplasm Using an 18-gauge Needle Electrode: Feasibility, Safety, and Technical Success. J Gastrointestin Liver Dis. 2018 Mar;27(1):67-72. doi: 10.15403/jgld.2014.1121.271.eus.

  PMID: 29557417 BACKGROUND

• Barthet M, Giovannini M, Lesavre N, Boustiere C, Napoleon B, Koch S, Gasmi M, Vanbiervliet G, Gonzalez JM. Endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors and pancreatic cystic neoplasms: a prospective multicenter study. Endoscopy. 2019 Sep;51(9):836-842. doi: 10.1055/a-0824-7067. Epub 2019 Jan 22.

  PMID: 30669161 BACKGROUND

• 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: 20541187 BACKGROUND

• Carrara S, Arcidiacono PG, Albarello L, Addis A, Enderle MD, Boemo C, Campagnol M, Ambrosi A, Doglioni C, Testoni PA. Endoscopic ultrasound-guided application of a new hybrid cryotherm probe in porcine pancreas: a preliminary study. Endoscopy. 2008 Apr;40(4):321-6. doi: 10.1055/s-2007-995595.

  PMID: 18389449 BACKGROUND

• 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: 25254586 BACKGROUND

• Di Matteo FM, Saccomandi P, Martino M, Pandolfi M, Pizzicannella M, Balassone V, Schena E, Pacella CM, Silvestri S, Costamagna G. Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma. Gastrointest Endosc. 2018 Jul;88(1):168-174.e1. doi: 10.1016/j.gie.2018.02.007. Epub 2018 Feb 13.

  PMID: 29452076 BACKGROUND

• Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2.

  PMID: 33278792 BACKGROUND

• Saccomandi P, Schena E, Caponero MA, Di Matteo FM, Martino M, Pandolfi M, Silvestri S. Theoretical analysis and experimental evaluation of laser-induced interstitial thermotherapy in ex vivo porcine pancreas. IEEE Trans Biomed Eng. 2012 Oct;59(10):2958-64. doi: 10.1109/TBME.2012.2210895. Epub 2012 Aug 23.

  PMID: 22929361 BACKGROUND

• Quero G, Saccomandi P, Kwak JM, Dallemagne B, Costamagna G, Marescaux J, Mutter D, Diana M. Modular laser-based endoluminal ablation of the gastrointestinal tract: in vivo dose-effect evaluation and predictive numerical model. Surg Endosc. 2019 Oct;33(10):3200-3208. doi: 10.1007/s00464-018-6603-4. Epub 2018 Nov 19.

  PMID: 30456508 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Francesco M Di Matteo

CONTACT

06225411657; f.dimatteo@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Operative Digestive Endoscopy department

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 22, 2022
• Study Start: February 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)