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

NCT02336672 | Completed DMC

• 1 other identifier: HTP/2014
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma Non-resectable

Keywords

Pancreatic adenocarcinoma; Cryothermoablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Response to treatment

  At 2 and 4 months after the treatment

• Evaluation of cell disruption / necrosis of the treated area

  At 2 and 4 months after the treatment

• Rate of resectability

  After 4 months pf treatment

• R0 Resection Rate:

  After surgical resection

Study Arms (2)

Group A Chemotherapy

NO INTERVENTION

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

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.

Device: Cryothermal ablation

Interventions

Cryothermal ablation 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.

Also known as: HybridTherm probe

Group B Chemotherapy + HybridTherm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pregnancy
• acute pancreatitis
• patients having distant metastasis

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele Irccs

Milan, MI, 20132, Italy

Location

Study Officials

• Paolo Giorgio Arcidiacono, MF FASGE

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pancreatico-Biliary and Endosonography Division

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 13, 2015
• Study Start: November 11, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IT (1)