EUS-guided Laser Ablation in Pancreatic Adenocarcinoma

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Terminated

CT.gov ID

NCT03784417

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma Pancreas Cancer	Device: EUS-guided laser ablation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2019

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of early and late adverse events after EUS-guided laser ablation (LA) [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.
Disease response to EUS-guided laser ablation (LA) [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
Post-procedural quality of life [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.
Progression-free-survival (PFS) [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.
Overall survival [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli	Roma	RM	Italy	00168
2	Universita' Cattolica del Sacro Cuore	Rome		Italy	00136

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Guido Costamagna, Professor, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT03784417

Other Study ID Numbers:

EUS-LASER

First Posted:

Dec 21, 2018

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Pancreatic Neoplasms

Study Results

No Results Posted as of Feb 28, 2022