Biliary ConditionDBC 01NCT04709666
Difficult Biliary Cannulation in Patients With Distal Malignant Biliary Obstruction: an Underestimated Problem
An observational study of Biliary Condition, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through the Vater's papilla. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Condition
- What is being tested?
- Endsocopic Retrograde ColangioPancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 31 Jul 2021
- 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: All patients will be recruited at the UO of Gastroenterology and digestive endoscopy of the participating centers
Who may be able to join
- With an age above or equal to 18,
- From which informed consent has been obtained,
- patients undergoing ERCP carried out by expert operators for DMBO due to pancreatico-biliary malignancies.
Who cannot join
- Patients who do not meet all of the listed inclusion criteria will be excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through the Vater's papilla. Difficult biliary cannulation (DBC) is a well-recognized risk factor for adverse events (AE) and cannulation failure, which has been reported in about 11% of ERCP regardless of their indication and a relevant heterogeneity in definition of DBC is present in the available studies. More recently, DBC during ERCP has been precisely defined by the European Society of Gastrointestinal Endoscopy (ESGE) as follows: more than 5 contacts with the papilla whilst attempting to cannulate; more than 5 minutes spent attempting to cannulate after visualization of the papilla; more than one unintended pancreatic duct cannulation or opacification (4). To date, the rate of DBC has not been calculated for specific sub-groups of ERCP indications. In particular, the rate of DBC in the setting of distal malignant biliary obstruction (DMBO), a frequent indication for ERCP, has not yet been described. DMBO is generally secondary to pancreatic adenocarcinoma, distal cholangiocarcinoma, ampullary carcinomas or adenopathy/metastasis from other cancers, and could potentially increase the complexity of the procedure as the tumor compression or infiltration alter the normal duodenal/papillary anatomy or determine duodenal rigidity.
In this study, we aimed to investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.
- Conditions
- Biliary Condition
- Being tested
- Endsocopic Retrograde ColangioPancreatography (ERCP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endsocopic Retrograde ColangioPancreatography (ERCP)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endsocopic Retrograde ColangioPancreatography (ERCP) | Endsocopic Retrograde ColangioPancreatography (ERCP) Receives: Procedure: Endsocopic Retrograde ColangioPancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of DBC
To investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2014
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ConditionStudies 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
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709666
- Sponsor's protocol ID
- 2143-2
- Acronym
- DBC 01
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2021
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficult Biliary Cannulation in Patients With Distal Malignant Biliary Obstruction: an Underestimated Problem
- ClinicalTrials.gov ID
- NCT04709666
- Acronym / sponsor ID
- DBC 01 / 2143-2
- Conditions
- Biliary Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 14 Jan 2021 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through the Vater's papilla. Difficult biliary cannulation (DBC) is a well-recognized risk factor for adverse events (AE) and cannulation failure, which has been reported in about 11% of ERCP regardless of their indication and a relevant heterogeneity in definition of DBC is present in the available studies. More recently, DBC during ERCP has been precisely defined by the European Society of Gastrointestinal Endoscopy (ESGE) as follows: more than 5 contacts with the papilla whilst attempting to cannulate; more than 5 minutes spent attempting to cannulate after visualization of the papilla; more than one unintended pancreatic duct cannulation or opacification (4). To date, the rate of DBC has not been calculated for specific sub-groups of ERCP indications. In particular, the rate of DBC in the setting of distal malignant biliary obstruction (DMBO), a frequent indication for ERCP, has not yet been described. DMBO is generally secondary to pancreatic adenocarcinoma, distal cholangiocarcinoma, ampullary carcinomas or adenopathy/metastasis from other cancers, and could potentially increase the complexity of the procedure as the tumor compression or infiltration alter the normal duodenal/papillary anatomy or determine duodenal rigidity.
In this study, we aimed to investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endsocopic Retrograde ColangioPancreatography (ERCP) | – | Procedure: Endsocopic Retrograde ColangioPancreatography (ERCP)Endsocopic Retrograde ColangioPancreatography (ERCP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be recruited at the UO of Gastroenterology and digestive endoscopy of the participating centers
Key inclusion criteria (3 listed)
- With an age above or equal to 18,
- From which informed consent has been obtained,
- patients undergoing ERCP carried out by expert operators for DMBO due to pancreatico-biliary malignancies.
Key exclusion criteria (1 listed)
- Patients who do not meet all of the listed inclusion criteria will be excluded from this study
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 |
|---|---|---|
| Endsocopic Retrograde ColangioPancreatography (ERCP) | Procedure or surgery | Endsocopic Retrograde ColangioPancreatography (ERCP) |
Primary outcome
Rate of DBC
Time frame: 6 Months
To investigate the rate of DBC and the outcome of patients undergoing ERCP for DMBO.
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 16 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Biliary Condition, run by Istituto Clinico Humanitas at 1 site in Italy.
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 3 inclusion and 1 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 16 Sep 2021. 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 Italy. 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?
Rate of DBC (time frame: 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 16 Sep 2021.