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

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Completed

CT.gov ID

NCT05155475

Collaborator

European Clinical Trial Experts Network (Other)

Enrollment

Location

6.5

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Jaundice Bilio-pancreatic Tumor	Procedure: Ultrasound endoscopy

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jun 4, 2019

Actual Primary Completion Date :

Dec 4, 2019

Actual Study Completion Date :

Dec 18, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Evaluation of the common bile duct size [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Jean Mermoz	Lyon		France	69008 Lyon

Sponsors and Collaborators

Ramsay Générale de Santé
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05155475

Other Study ID Numbers:

2018-A03461-54

First Posted:

Dec 13, 2021

Last Update Posted:

Dec 13, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Jaundice

Jaundice, Obstructive

Study Results

No Results Posted as of Dec 13, 2021