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

NCT ID: NCT05155475

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-04

Study Completion Date

2019-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Jaundice Bilio-pancreatic Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with jaundice

Ultrasound endoscopy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Jean Mermoz

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2018-A03461-54

Identifier Type: -

Identifier Source: org_study_id