Pancreatic Adenocarcinoma Non-resectable Clinical Trial
Official title:
EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma
Verified date | September 2023 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a re-sectable disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - pathological diagnosis - patients with borderline resectable/locally advanced pancreatic adenocarcinoma; - patients no previously treated with neoadjuvant treatments, irrespective of the regimen - age >18 years; = 80 - genders eligible for study: both - patients who can express their consent - Karnofsky Performance status >70; - Life expectancy >6 months. - PLT>100000/mcl; INR<1.5. - adequate renal function with a creatinine threshold - adequate bone marrow function (WBC =3500) Exclusion Criteria: - pregnancy - acute pancreatitis - patients having distant metastasis |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Raffaele Irccs | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | To demonstrate the efficacy of the HybridTherm probe in the control of the tumour progression in terms of progression-free survival, measured at 6-month after ther-apy onset (PFS-6). PFS-6 takes in consideration the tumor growth in relation to the volume/size evaluated as a difference between the previous and the current examination. In practice, it is the time interval between the enrolment of the patient and the first radiological evidence of tumor progression. For patients who were resected (R0 and R1) the PFS is the time until the first radio-logical evidence of tumor recurrence, regardless size. For not resected patients the PFS is the time until the first radiological evidence of a growth of the lesion > 20% in comparison to the previous exam. |
6-months after therapy onset | |
Secondary | Response to treatment | Evaluated by the radiological response to the treatment calculated on the differ-ences of radiological images (DW-MRI) before treatment onset and after two and four month of treatment | At 2 and 4 months after the treatment | |
Secondary | Evaluation of cell disruption / necrosis of the treated area | Measured with the Apparent Diffusion Coefficient in the dw-MRI which will be per-formed at the time of patients' enrolment, after HTP treatment (Group B) and after two and four month of treatment. | At 2 and 4 months after the treatment | |
Secondary | Rate of resectability | Evaluated by the number of resectable patients after four month of treatment | After 4 months pf treatment | |
Secondary | R0 Resection Rate: | Evaluated by the number of R0 resections for those patients who were submitted to sur-gery (see Rate of resectability) on the basis of the pathologists finding | After surgical resection |
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