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

Completed

• Conditions: Obstructive Jaundice; Bilio-pancreatic Tumor
• Interventions: Procedure: Ultrasound endoscopy

• Registration Number: NCT05155475
• Lead Sponsor: Ramsay Générale de Santé

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-04
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-18
• Status Verified: 2021-11
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with jaundice	Ultrasound endoscopy	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the common bile duct size	1 day

Trial Locations

Locations (1)

Hôpital Jean Mermoz; 🇫🇷 Lyon, France