Clinical trial · Interventional
EUS-guided Laser Ablation in Pancreatic Adenocarcinoma
EUS-guided Laser Complete Ablation of Advanced Pancreatic Ductal Adenocarcinoma: a Feasibility Study
NCT03784417CI-TRIAL-00056793terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): device unavalaible
Summary
Brief summary (as posted)
This study evaluates the possibility of performing local therapy for PDAC using laser ablation of the tumor under ultrasonography (EUS) guidance. Safety of the procedure as well as post procedural quality of life will be also evaluated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided laser ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS-guided laser ablation
- description
- Laser ablation will be performed using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge needle under endoscopic ultrasonography guidance.
- interventionNames
- Device: EUS-guided laser ablation
Primary outcomes (1)
- measure
- Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor
- timeFrame
- at 1 month from the intervention
- description
- Number of patients with necrosis of the tumor, as demonstrated by the involution of the pancreatic mass on CT scan performed after one month from the treatment
Secondary outcomes (5)
- measure
- Incidence of early and late adverse events after EUS-guided laser ablation (LA)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of pancreatic ductal adenocarcinoma * Unresectable advanced, non-metastatic Stage III tumor * Stable disease without regression or progression after 6 months of chemotherapeutic treatment * Locally progressive disease after chemiotherapy, without evidence of metastases * Age \>18 and \<80 years * Willing to be followed up c/o the Fondazione Policlinico A. Gemelli University Hospital * Signed informed consent Exclusion Criteria: * Stage I, Stage II, Stage IV disease * Absolute contraindications to general anesthesia or deep sedation * Absolute contraindications to perform digestive endoscopy * Known bleeding disorder that cannot be sufficiently corrected with co-fact 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 * Unable to sigh informed consent
References
Publications (14)
- BACKGROUNDGordon-Dseagu VL, Devesa SS, Goggins M, Stolzenberg-Solomon R. Pancreatic cancer incidence trends: evidence from the Surveillance, Epidemiology and End Results (SEER) population-based data. Int J Epidemiol. 2018 Apr 1;47(2):427-439. doi: 10.1093/ije/dyx232. PMID 29149259
- BACKGROUNDRyan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Nov 27;371(22):2140-1. doi: 10.1056/NEJMc1412266. No abstract available. PMID 25427123
- 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
- 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
- BACKGROUNDKim HJ, Seo DW, Hassanuddin A, Kim SH, Chae HJ, Jang JW, Park DH, Lee SS, Lee SK, Kim MH. EUS-guided radiofrequency ablation of the porcine pancreas. Gastrointest Endosc. 2012 Nov;76(5):1039-43. doi: 10.1016/j.gie.2012.07.015. PMID 23078928
- Francica G, Petrolati A, Di Stasio E, Pacella S, Stasi R, Pacella CM. Effectiveness, safety, and local progression after percutaneous laser ablation for hepatocellular carcinoma nodules up to 4 cm are not affected by tumor location. AJR Am J Roentgenol. 2012 Dec;199(6):1393-401. doi: 10.2214/AJR.11.7850.