Clinical trial · Interventional
Pre-planning Mathematical Models in EUS-guided Laser Ablation of Pancreatic Lesions
Use of Pre-planning Models for the Guidance of the Endoscopic Ultrasound-guided Laser Ablation of Pancreatic Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The medical device used in this study is a 980 nm wavelength diode laser with maximum output of 30 W (EUFOTON Laser Spectrum). | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- pancreatic lesions
- description
- 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.
- interventionNames
- Device: The medical device used in this study is a 980 nm wavelength diode laser with maximum output of 30 W (EUFOTON Laser Spectrum).
Primary outcomes (1)
- measure
- Feasibility of pre-planned laser setting in lesion ablation
- timeFrame
- 1,3,6 months
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (16)
- BACKGROUNDLakhtakia 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
- BACKGROUNDHan 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
- BACKGROUNDRuarus 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
- BACKGROUNDGirelli 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
- BACKGROUNDGirelli 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
- BACKGROUNDSong 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
- BACKGROUNDScopelliti 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.