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

NCT ID: NCT02336672

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-11
• Study Completion Date: 2021-12-31

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.

Conditions

Pancreatic Adenocarcinoma Non-resectable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A Chemotherapy

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 Type: NO_INTERVENTION

No interventions assigned to this group

Group B Chemotherapy + HybridTherm

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.

Group Type: EXPERIMENTAL

Cryothermal ablation

Intervention Type: DEVICE

Procedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization.

Interventions

Cryothermal ablation

Procedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization.

Intervention Type: DEVICE

Other Intervention Names

HybridTherm probe

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Paolo Giorgio Arcidiacono, MD

Head of Pancreatico-Biliary and Endosonography Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Giorgio Arcidiacono, MF FASGE

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

Ospedale San Raffaele Irccs

Milan, MI, Italy

Countries

Italy

Other Identifiers

HTP/2014

Identifier Type: -

Identifier Source: org_study_id