EUS-guided Laser Ablation in Pancreatic Adenocarcinoma
Raktažodžiai
Santrauka
apibūdinimas
Pancreatic adenocarcinoma (PDAC) is projected to be the second cause of cancer death in Western societies within a decade. Management include chemotherapy and/or radiation therapy, while resectable disease is possible only in 15% of cases.
Despite these therapeutic approaches, the survival rate of unresectable pancreatic cancer remains disappointing. Recently, there is a growing interest in the development of alternative therapeutic approaches, which can work in parallel with standard chemoradiation therapy. These methods include intra-lesion injection/instillation of antitumoral agents performed through a laparoscopic approach, or percutaneously or under endoscopic ultrasound (EUS) guidance and tumor volume reduction procedures using ablative techniques.
In this context laser ablation has been reported to be effective in inducing coagulative necrosis of the tumour in absence of major adverse events. However, the available studies on the matter are limited by small sample size, lack of extended follow up and informations about the possibility to ablate the entire tumour mass.
Datos
| Paskutinį kartą patikrinta: | 01/31/2020 |
| Pirmasis pateikimas: | 11/24/2018 |
| Numatytas registravimas pateiktas: | 12/19/2018 |
| Pirmas paskelbtas: | 12/20/2018 |
| Paskutinis atnaujinimas pateiktas: | 02/05/2020 |
| Paskutinis atnaujinimas paskelbtas: | 02/09/2020 |
| Faktinė studijų pradžios data: | 10/14/2019 |
| Numatoma pirminio užbaigimo data: | 09/14/2021 |
| Numatoma studijų užbaigimo data: | 09/14/2021 |
Būklė ar liga
Intervencija / gydymas
Device: EUS-guided laser ablation
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: EUS-guided laser ablation 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. | Device: EUS-guided laser ablation EUS-guided LA will be performed with an endoscopic ultrasound guided approach using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge flexible needle that is inserted in the working channel of the echoendoscope. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor [at 1 month from the intervention]
Antrinės rezultatų priemonės
1. Incidence of early and late adverse events after EUS-guided laser ablation (LA) [at 7 days and 3 months from the intervention]
2. Disease response to EUS-guided laser ablation (LA) [From date of treatment, every 4 months, assessed until death or up to 2 years]
3. Post-procedural quality of life [From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years]
4. Progression-free-survival (PFS) [From date of enrollment assessed until death or up to 2 years]
5. Overall survival [From date of enrollment assessed until death or up to 2 years]
