Intraoperative Endoscopic Ultrasound for Pancreatic Cancer (EchoSurg)

January 5, 2024 updated by: IHU Strasbourg

Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer

Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nowadays pancreatic cancer is one of the deadliest oncological pathologies today. Even after curative surgery, considered the only effective curative tool, 5-years survival does not exceed 5%. Before surgery, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. However, the evaluation being devoted to the pancreas, this study wishes to extend echoendoscopie to lymph node staging away from the surgical field. The proposed study is based on the hypothesis that the implementation of a simple classification of lymph nodes, based on non-invasive ultrasound criteria, would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

At the same time, the video data obtained will be collected in a computer database in order to create an artificial intelligence lesion detection and qualification tool.

This study plans to recruit 45 adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection (first line and after neoadjuvant treatment) is planned. The main objective is to estimate the sensitivity and specificity of a simple classification "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).

Study Type

Interventional

Enrollment (Estimated)

45

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 Contact

Study Locations

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 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient over 18 years old
  2. Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
  3. Patient with a complete clinical examination performed
  4. Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
  5. Patient able to receive and understand information relating to the study and give informed written consent
  6. Patient affiliated to the French social security system

Exclusion Criteria:

  1. Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT <60%, TCA> 40 s and platelets <60,000 / mm3)
  2. Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
  3. Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
  4. Pregnant or breastfeeding patient
  5. Patient in exclusion period (determined by a previous study or in progress)
  6. Patient under legal protection
  7. Patient under guardianship or trusteeship

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripancreatic and distant lymph node assessment
All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer
Diagnostic test: Echoendoscopy
Peripancreatic lymph nodes and at a distance from the pancreas assessment by endoscopic ultrasound, elastography an doppler to record their anatomical location and characteristics. All lymph nodes suspected of metastatic disease will be marked with sterile black ink.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
Time Frame: 1 month
Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
1 month
Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
Time Frame: 1 month
Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of metastases actually diagnosed
Time Frame: 1 month
Comparison between the number of suspected lymph nodes identified during preoperative endoscopic ultrasound and results of the histological analysis of these resected lymph nodes.
1 month
Location of hidden lymph node metastases
Time Frame: 1 day
Description of the location of hidden lymph node metastases identified by endoscopic ultrasound
1 day
Number of distant nodes detected during the endoscopic ultrasound
Time Frame: 1 day
Number of distant nodes detected during the preoperative endoscopic ultrasound
1 day
Number of distant malignant lymph nodes
Time Frame: 1 month
Number of distant lymph nodes detected during the preoperative endoscopic ultrasound and whose malignancy has been confirmed by the gold standard
1 month
Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound
Time Frame: 1 day
Number of patients for whom a contraindication to surgery has been detected during the endoscopic ultrasound, on the total number of patients included.
1 day
Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site
Time Frame: 1 day
Number of patients for whom elastography was required to identify distant hidden lymph node metastases
1 day
Measurement of the operating time required to perform preoperative elastography
Time Frame: 1 day
Measurement of the operating time (in minutes) required to perform preoperative elastography.
1 day
Measurement of the additional costs generated by materials required for preoperative elastography
Time Frame: 1 day
Measurement of the additional costs (in euros) generated by materials required for preoperative elastography in resectable pancreas cancer patients
1 day
Impact of sterile black ink marking of distant nodes during the preoperative EA
Time Frame: 1 day
Analysis of the impact of sterile black ink marking of distant lymph nodes during preoperative ultrasound endoscopy on the surgical procedure by the mean of a questionnaire completed by the surgeon. This questionnaire will be assessed by a score of Likert varying between 1 (not satisfied) and 5 (very satisfied).
1 day
Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence
Time Frame: 1 day
Deep learning-based analysis of video data from the ultrasound endoscopy
1 day
Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence
Time Frame: 1 day
Deep learning-based analysis of video data from the ultrasound endoscopy
1 day

Collaborators and Investigators

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

Sponsor

IHU Strasbourg

Investigators

  • Principal Investigator: Patrick Pessaux, MD, Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC Strasbourg

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)

December 5, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-007

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

product manufactured in and exported from the U.S.

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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