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

Not Applicable

Completed

• Conditions: Pancreatic Adenocarcinoma Non-resectable
• Interventions: Device: Cryothermal ablation

• Registration Number: NCT02336672
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-11-11
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2018-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B Chemotherapy + HybridTherm	Cryothermal ablation	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival	6-months after therapy onset	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of cell disruption / necrosis of the treated area	At 2 and 4 months after the treatment	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.
R0 Resection Rate:	After surgical resection	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
Rate of resectability	After 4 months pf treatment	Evaluated by the number of resectable patients after four month of treatment
Response to treatment	At 2 and 4 months after the 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

Trial Locations

Locations (1)

Ospedale San Raffaele Irccs; 🇮🇹 Milan, MI, Italy