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

NCT05155475 | Completed

• 1 other identifier: 2018-A03461-54
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Jaundice; Bilio-pancreatic Tumor

Outcome Measures

Primary Outcomes (1)

• Evaluation of the common bile duct size

  1 day

Study Arms (1)

Patient with jaundice

Procedure: Ultrasound endoscopy

Interventions

Ultrasound endoscopy 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

Patient with jaundice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old, with jaundice

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital Jean Mermoz

Lyon, 69008 Lyon, France

Location

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: June 4, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 18, 2019
• Last Updated: December 13, 2021

Record last verified: 2021-11

Locations

FR (1)