Endoscopic Ultrasound Evaluation Of The Common Bile Duct In Patients With Obstructive Jaundice Due To Bilio-pancreatic Malignancies (ECCO Trial)

Study Overview

Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies (ECCO Trial)

To assess the size of the common bile duct in a large cohort of patients with jaundice following a malignant tumor of the head of the pancreas or the distal bile duct receiving a diagnostic EA for biopsy and / or for evaluation of tissue resectability.

N/A

Obstructive Jaundice
Bilio-pancreatic Tumor

PROCEDURE: Ultrasound endoscopy

2018-A03461-54

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-11-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-11-30
First Submitted that Met QC Criteria 2021-11-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-12-13
First Posted (ACTUAL) 2021-12-13	Results First Posted N/A	Last Verified 2021-11

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Patient with jaundice	PROCEDURE: Ultrasound endoscopy After identification of the lesion, the common bile duct will be identified and followed by the point of dilation due to the compression of the known lesion up to the hilum of the liver

Participant Group/Arm

Intervention/Treatment

: Patient with jaundice

PROCEDURE: Ultrasound endoscopy

After identification of the lesion, the common bile duct will be identified and followed by the point of dilation due to the compression of the known lesion up to the hilum of the liver

Primary Outcome Measures	Measure Description	Time Frame
Evaluation of the common bile duct size		1 day

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients with jaundice and an injury to the head of the pancreas recommended for EUS-guided tissue acquisition or staging
Patients with jaundice and distal CBD lesion suggestive of cholangiocarcinoma or Vater's ampulla carcinoma recommended for EUS-guided tissue acquisition or staging
Serum bilirubin level ≥ 3 mg / dl
Age ≥ 18 years old
Subject affiliated or beneficiary of a social security scheme.
Subject having been informed of this study and having given his no objection

Presence of altered anatomy due to previous gastric surgery (Billroth II or Roux-en-Y anastomosis)
Sphincterotomy performed previously, plastic biliary stent or metal stent placement
Percutaneous drainage of the bile ducts performed previously
Pregnant, breastfeeding or parturient woman
Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; hospitalized without consent.

Collaborators and Investigators

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

European Clinical Trial Experts Network

Investigators

Publications

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

General Publications

No publications available

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Clinical Trial Record