EUS-guided Laser Ablation in Pancreatic Adenocarcinoma

February 10, 2022 updated by: Guido Costamagna, Catholic University of the Sacred Heart

EUS-guided Laser Complete Ablation of Advanced Pancreatic Ductal Adenocarcinoma: a Feasibility Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pancreatic adenocarcinoma (PDAC) is projected to be the second cause of cancer death in Western societies within a decade. Management include chemotherapy and/or radiation therapy, while resectable disease is possible only in 15% of cases.

Despite these therapeutic approaches, the survival rate of unresectable pancreatic cancer remains disappointing. Recently, there is a growing interest in the development of alternative therapeutic approaches, which can work in parallel with standard chemoradiation therapy. These methods include intra-lesion injection/instillation of antitumoral agents performed through a laparoscopic approach, or percutaneously or under endoscopic ultrasound (EUS) guidance and tumor volume reduction procedures using ablative techniques.

In this context laser ablation has been reported to be effective in inducing coagulative necrosis of the tumour in absence of major adverse events. However, the available studies on the matter are limited by small sample size, lack of extended follow up and informations about the possibility to ablate the entire tumour mass.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00136
        • Universita' Cattolica del Sacro Cuore
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EUS-guided laser ablation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor necrosis induction by EUS-guided laser ablation (LA) - Number of patients with necrosis of the tumor
Time Frame: at 1 month from the intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of early and late adverse events after EUS-guided laser ablation (LA)
Time Frame: at 7 days and 3 months from the intervention
Percentage of early and late adverse events. Early adverse events will be those occurring during the procedure up to the first week after the ablation treatment. Late adverse events will be defined as any adverse event potentially related to the procedure occurring at the site of the primary tumor within 3 months after EUS LA treatment. Adverse events will be considered major if they prevent completion of the scheduled procedure and/or resulted in prolongation of hospital stay, another therapeutic procedure (needing sedation/anesthesia), or subsequent medical consultation. Any potential adverse event such as pancreatitis, burns of the gastric or duodenal walls, bowel injury, or peritonitis will be recorded and graded according to the above-mentioned classification.
at 7 days and 3 months from the intervention
Disease response to EUS-guided laser ablation (LA)
Time Frame: From date of treatment, every 4 months, assessed until death or up to 2 years
Correlation between RNA markers evaluated by TaqMan RNA assay in serum and treatment response
From date of treatment, every 4 months, assessed until death or up to 2 years
Post-procedural quality of life
Time Frame: From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years
Change from baseline in quality of life (QOL) scores after treatment evaluated by using the European Organization for Research and Treatment core quality of life questionnaire (EORTC QLQ-C30), version 3.0. EORTC QLQ-C30 questionnaire evaluates 5 functions physical,role,cognitive, emotional, and social), 9 symptoms (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties) and the global health status. Questions regarding functions and symptoms are scored 1 to 4, with higher values representing a worse outcomes. Questions regarding global health status are scored 1 to 7, with higher values representing better outcomes.
From date of enrollment (baseline), every 2 months, assessed until death or up to 2 years
Progression-free-survival (PFS)
Time Frame: From date of enrollment assessed until death or up to 2 years
PFS defined as the time from the date of trial entry until disease progression or relapse.
From date of enrollment assessed until death or up to 2 years
Overall survival
Time Frame: From date of enrollment assessed until death or up to 2 years
Overall survival defined as the length of time (in days) between the treatment date and the date of death.
From date of enrollment assessed until death or up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Alberto Larghi, PhD, Fondazione Policlinico Universitario Agostino Gemelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS-LASER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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