Pancreatic CancerECCONCT03494023
EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice
An observational study of Pancreatic Cancer and Cholangiocarcinoma of the Extrahepatic Bile Duct, run by Clinical Hospital Colentina at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampulla of Vater Cancer
- What is being tested?
- Endoscopic ultrasound
- How many people
- 539 participants
- Where
- 1 siteRomania
- Study dates
- 27 Mar 2018to 15 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Romania1 site
Gastroenterology Department, Clinical Hospital Colentina
Bucharest, 020125
About this study
Official title: Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampulla of Vater Cancer, Jaundice, Obstructive
- Being tested
- Endoscopic ultrasound
- Medical subject headings
- Pancreatic Neoplasms, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundDiagnostic test
Measurement of the common bile duct diameter
What is being measured
The primary outcome is the main question the study is designed to answer.
Common bile duct diameter
Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice
Measured: Enrollment over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start27 Mar 2018
- Primary completion31 Dec 2019
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University, Italy
- Responsible party
- Principal investigator, Mihai Rimbas, Clinical Hospital Colentina
- Investigators
- Mihai Rimbas, MD, PhD, Principal investigator, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494023
- Sponsor's protocol ID
- Col-gastro 7
- Acronym
- ECCO
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03494023
- Acronym / sponsor ID
- ECCO / Col-gastro 7
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampulla of Vater Cancer, Jaundice, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Collaborators
- Catholic University, Italy
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasoundMeasurement of the common bile duct diameter | Diagnostic test | – |
Primary outcome
Common bile duct diameter
Time frame: Enrollment over 6 months
Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihai Rimbas, MD, PhD principal investigator
Clinical Hospital Colentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Cholangiocarcinoma of the Extrahepatic Bile Duct, run by Clinical Hospital Colentina at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common bile duct diameter (time frame: Enrollment over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.