EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)

San Donato Group (GSD)

Status: Completed

Conditions: Pancreatic Adenocarcinoma Non-resectable

Treatments: Device: Cryothermal ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02336672

HTP/2014

Details and patient eligibility

About

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.

Full description

About 40% of patients with pancreatic cancer have no metastasis at the moment of diagnosis, but in 20% of patients surgery is not feasible due to vascular invasion or poor general conditions. These patients with stage III pancreatic cancer (locally advanced or borderline resectable) may benefit from neoadjuvant chemotherapy or chemoradiotherapy. The HybridTherm probe is a new, minimally invasive device that can be safely applied under EUS guidance to locally ablate the pancreatic tissue adding a local efficacy to the systemic activity offered by chemotherapy and could give these patients a bigger chance of survival. The present study is an interventional randomized controlled phase II/III trial (device), that assigns patients into two groups: patients receiving standard chemotherapy alone and those receiving chemotherapy plus EUS-guided HybridTherm ablation. The randomization is performed at the time of EUS diagnosis and staging.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Group A Chemotherapy

No Intervention group

Description:

Patients receiving chemotherapy alone. These patients start standard chemotherapy right after the oncologist's evaluation according to accepted Guidelines of the Italian Association of Medical Oncologists (AIOM). Restaging is performed 2, 4 and 6 months after chemotherapy onset, with MDCT scan and DW-MRI.

Group B Chemotherapy + HybridTherm

Experimental group

Description:

Patients receiving chemotherapy plus EUS-guided Cryothermal Ablation with HybridTherm probe. These patients are first treated by cryothermal ablation and one week after they start with chemotherapy. Cryothermal ablation can be performed up to three times, with interval of 4 +/- 1 weeks. Restaging is performed 2, 4 and 6 months after chemotherapy onset, with MDCT scan and DW-MRI.

Treatment:

Device: Cryothermal ablation