EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06341725
• Other study ID #: LinfoK EUS 2016
• Status: Terminated
• Start date: February 15, 2018
• Est. completion date: September 11, 2018

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)

• in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).

• in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.

Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature)

Description:

Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 11, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: pancreatic adenocarcinoma without distant metastasis; patients > 18 years

Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma

Related Conditions & MeSH terms

• Adenocarcinoma
• Lymph Node Metastasis
• Lymphatic Metastasis
• Pancreatic Adenocarcinoma

Intervention

Other:
• malignant lymph nodes
observational study

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Giorgio Arcidiacono, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report	resectable pancreatic cancer	2 years
Primary	OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence	resectable pancreatic cancer	2 years
Primary	OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence	borderline resectable and locally advanced pancreatic cancer	2 years
Secondary	OVERALL SURVIVAL (MONTHS)	para-aortic and mediasitnum metastatic lymph nodes presence	2 years