Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Jaundice"

EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice (ECCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03494023
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Catholic University, Italy
Information provided by (Responsible Party):
Mihai Rimbas, Clinical Hospital Colentina

Brief Summary:
The main objective of the study is to evaluate the size of the common bile duct (CBD) in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

Condition or disease Intervention/treatment
Pancreatic Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Ampulla of Vater Cancer Jaundice, Obstructive Diagnostic Test: Endoscopic ultrasound

Detailed Description:

Rationale: The size of the common bile duct (CBD) may influence the type of stent used and the type of the procedure performed in cases of EUS-guided biliary drainage. However, no data of the size of the CBD in patients with jaundice presenting with a pancreatic head mass or with a distal cholangiocarcinoma/ carcinoma of the ampulla of Vater are available.

Objectives: To evaluate the size of the CBD in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

Study design: International prospective observational multicenter trial. Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling or evaluation of resectability of a pancreatic, a distal bile duct lesion or a carcinoma of the ampulla of Vater determining obstructive jaundice.

Intervention: EUS examination Main study parameters/endpoints: measurement of the CBD in patients with an obstructive distal biliary mass. Determine the factors associated with a CBD greater than 15mm Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Measurement of the CBD during EUS examination does not add additional risks to the procedure.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • Diagnostic Test: Endoscopic ultrasound
    Measurement of the common bile duct diameter


Primary Outcome Measures :
  1. Common bile duct diameter [ Time Frame: Enrollment over 6 months ]
    Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study concerns individuals with jaundice with an indication for EUS examination of a pancreatic head solid lesion, a distal CBD mass, or a carcinoma of the ampulla of Vater who undergo diagnostic EUS-guided tissue acquisition or for evaluation of resectability, discovered at previously performed imaging studies. Only patients with a definitive diagnosis of neoplasia will enter in the final analysis. Eligible individuals will be recruited by endosonographers among the centers of the ECCO study group.
Criteria

Inclusion Criteria:

  • Patients with jaundice and a pancreatic head mass lesion referred for EUS-guided tissue acquisition or staging
  • Patients with jaundice and a distal CBD lesion suggestive of cholangiocarcinoma or a carcinoma of the ampulla of Vater referred for EUS-guided tissue acquisition or staging
  • Serum bilirubin level ≥3 mg/dL
  • Age ≥18 years
  • Written informed consent

Exclusion Criteria:

  • Presence of altered anatomy from previous gastric surgery (Billroth II or Roux-en-Y anastomosis)
  • Previously performed sphincterotomy, biliary plastic stent or metal stent placement
  • Previous percutaneous drainage of the bile duct
  • Pregnancy
  • Inability to sign the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494023


Contacts
Layout table for location contacts
Contact: Mihai Rimbas, MD, PhD 0040213173245 ext 5118 mrimbas@gmail.com
Contact: Alberto Larghi, MD, PhD alberto.larghi@yahoo.com

Locations
Layout table for location information
Romania
Gastroenterology Department, Clinical Hospital Colentina Recruiting
Bucharest, Romania, 020125
Contact: Mihai Rimbas, MD, PhD    +40723232052    mrimbas@gmail.com   
Principal Investigator: Mihai Rimbas, MD, PhD         
Sponsors and Collaborators
Clinical Hospital Colentina
Catholic University, Italy
Investigators
Layout table for investigator information
Principal Investigator: Mihai Rimbas, MD, PhD Clinical Hospital Colentina

Layout table for additonal information
Responsible Party: Mihai Rimbas, Assistant Professor, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT03494023     History of Changes
Other Study ID Numbers: Col-gastro 7
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Jaundice
Jaundice, Obstructive
Pancreatic Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms