NCT03784417

Brief Summary

This study evaluates the possibility of performing local therapy for PDAC using laser ablation of the tumor under ultrasonography (EUS) guidance. Safety of the procedure as well as post procedural quality of life will be also evaluated.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

November 25, 2018

Last Update Submit

February 10, 2022

Conditions

Pancreatic AdenocarcinomaPancreas Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor

    Number of patients with necrosis of the tumor, as demonstrated by the involution of the pancreatic mass on CT scan performed after one month from the treatment

    at 1 month from the intervention

Secondary Outcomes (5)

  • Incidence of early and late adverse events after EUS-guided laser ablation (LA)

    at 7 days and 3 months from the intervention

  • Disease response to EUS-guided laser ablation (LA)

    From date of treatment, every 4 months, assessed until death or up to 2 years

  • Post-procedural quality of life

    From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years

  • Progression-free-survival (PFS)

    From date of enrollment assessed until death or up to 2 years

  • Overall survival

    From date of enrollment assessed until death or up to 2 years

Study Arms (1)

EUS-guided laser ablation

EXPERIMENTAL

Laser ablation will be performed using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge needle under endoscopic ultrasonography guidance.

Device: EUS-guided laser ablation

Interventions

EUS-guided laser ablationDEVICE

EUS-guided LA will be performed with an endoscopic ultrasound guided approach using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge flexible needle that is inserted in the working channel of the echoendoscope.

EUS-guided laser ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of pancreatic ductal adenocarcinoma
  • Unresectable advanced, non-metastatic Stage III tumor
  • Stable disease without regression or progression after 6 months of chemotherapeutic treatment
  • Locally progressive disease after chemiotherapy, without evidence of metastases
  • Age \>18 and \<80 years
  • Willing to be followed up c/o the Fondazione Policlinico A. Gemelli University Hospital
  • Signed informed consent

You may not qualify if:

  • Stage I, Stage II, Stage IV disease
  • Absolute contraindications to general anesthesia or deep sedation
  • Absolute contraindications to perform digestive endoscopy
  • Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
  • Use of anticoagulants that cannot be discontinued
  • International Normalized Ratio (INR) \>1.5 or platelet count \<50.000
  • Pregnancy or lactation
  • Unable to sigh informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00168, Italy

Location

Universita' Cattolica del Sacro Cuore

Rome, 00136, Italy

Location

Related Publications (14)

  • Gordon-Dseagu VL, Devesa SS, Goggins M, Stolzenberg-Solomon R. Pancreatic cancer incidence trends: evidence from the Surveillance, Epidemiology and End Results (SEER) population-based data. Int J Epidemiol. 2018 Apr 1;47(2):427-439. doi: 10.1093/ije/dyx232.

    PMID: 29149259BACKGROUND

  • Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Nov 27;371(22):2140-1. doi: 10.1056/NEJMc1412266. No abstract available.

    PMID: 25427123BACKGROUND

  • Lakhtakia S, Seo DW. Endoscopic ultrasonography-guided tumor ablation. Dig Endosc. 2017 May;29(4):486-494. doi: 10.1111/den.12833. Epub 2017 Mar 16.

    PMID: 28171697BACKGROUND

  • Han J, Chang KJ. Endoscopic Ultrasound-Guided Direct Intervention for Solid Pancreatic Tumors. Clin Endosc. 2017 Mar;50(2):126-137. doi: 10.5946/ce.2017.034. Epub 2017 Mar 30.

    PMID: 28391669BACKGROUND

  • Girelli R, Frigerio I, Salvia R, Barbi E, Tinazzi Martini P, Bassi C. Feasibility and safety of radiofrequency ablation for locally advanced pancreatic cancer. Br J Surg. 2010 Feb;97(2):220-5. doi: 10.1002/bjs.6800.

    PMID: 20069610BACKGROUND

  • Girelli R, Frigerio I, Giardino A, Regi P, Gobbo S, Malleo G, Salvia R, Bassi C. Results of 100 pancreatic radiofrequency ablations in the context of a multimodal strategy for stage III ductal adenocarcinoma. Langenbecks Arch Surg. 2013 Jan;398(1):63-9. doi: 10.1007/s00423-012-1011-z. Epub 2012 Sep 29.

    PMID: 23053459BACKGROUND

  • Kim HJ, Seo DW, Hassanuddin A, Kim SH, Chae HJ, Jang JW, Park DH, Lee SS, Lee SK, Kim MH. EUS-guided radiofrequency ablation of the porcine pancreas. Gastrointest Endosc. 2012 Nov;76(5):1039-43. doi: 10.1016/j.gie.2012.07.015.

    PMID: 23078928BACKGROUND

  • Francica G, Petrolati A, Di Stasio E, Pacella S, Stasi R, Pacella CM. Effectiveness, safety, and local progression after percutaneous laser ablation for hepatocellular carcinoma nodules up to 4 cm are not affected by tumor location. AJR Am J Roentgenol. 2012 Dec;199(6):1393-401. doi: 10.2214/AJR.11.7850.

    PMID: 23169736BACKGROUND

  • Di Matteo F, Martino M, Rea R, Pandolfi M, Rabitti C, Masselli GM, Silvestri S, Pacella CM, Papini E, Panzera F, Valeri S, Coppola R, Costamagna G. EUS-guided Nd:YAG laser ablation of normal pancreatic tissue: a pilot study in a pig model. Gastrointest Endosc. 2010 Aug;72(2):358-63. doi: 10.1016/j.gie.2010.02.027. Epub 2010 Jun 11.

    PMID: 20541187BACKGROUND

  • Carrara S, Arcidiacono PG, Albarello L, Addis A, Enderle MD, Boemo C, Campagnol M, Ambrosi A, Doglioni C, Testoni PA. Endoscopic ultrasound-guided application of a new hybrid cryotherm probe in porcine pancreas: a preliminary study. Endoscopy. 2008 Apr;40(4):321-6. doi: 10.1055/s-2007-995595.

    PMID: 18389449BACKGROUND

  • Di Matteo FM, Saccomandi P, Martino M, Pandolfi M, Pizzicannella M, Balassone V, Schena E, Pacella CM, Silvestri S, Costamagna G. Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma. Gastrointest Endosc. 2018 Jul;88(1):168-174.e1. doi: 10.1016/j.gie.2018.02.007. Epub 2018 Feb 13.

    PMID: 29452076BACKGROUND

  • Di Matteo F, Picconi F, Martino M, Pandolfi M, Pacella CM, Schena E, Costamagna G. Endoscopic ultrasound-guided Nd:YAG laser ablation of recurrent pancreatic neuroendocrine tumor: a promising revolution? Endoscopy. 2014;46 Suppl 1 UCTN:E380-1. doi: 10.1055/s-0034-1377376. Epub 2014 Sep 25. No abstract available.

    PMID: 25254586BACKGROUND

  • Gress TM, Lausser L, Schirra LR, Ortmuller L, Diels R, Kong B, Michalski CW, Hackert T, Strobel O, Giese NA, Schenk M, Lawlor RT, Scarpa A, Kestler HA, Buchholz M. Combined microRNA and mRNA microfluidic TaqMan array cards for the diagnosis of malignancy of multiple types of pancreatico-biliary tumors in fine-needle aspiration material. Oncotarget. 2017 Nov 21;8(64):108223-108237. doi: 10.18632/oncotarget.22601. eCollection 2017 Dec 8.

    PMID: 29296236BACKGROUND

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PMID: 8433390BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Alberto Larghi, PhD

    Fondazione Policlinico Universitario Agostino Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2018

First Posted

December 21, 2018

Study Start

October 15, 2019

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)