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NCT05155475 Clinical Trial

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

Obstructive Jaundice Clinical Trial

— ECCO  

Official title:
Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies: a Multicenter Prospective Study (ECCO Trial)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05155475
Other study ID # 2018-A03461-54
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 4, 2019
Est. completion date December 18, 2019

Study information
Verified date November 2021
Source Ramsay Générale de Santé
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 18, 2019
Est. primary completion date December 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hôpital Jean Mermoz Lyon

Sponsors (2)
Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the common bile duct size 1 day
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