CholangiocarcinomaERDBNCT05187312
Registry for Advanced Endoscopy
An observational study of Cholangiocarcinoma and Pancreatic Cancer, run by Region Stockholm at 1 site in Sweden.
Trial summary
Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Pancreatic Cancer, Sclerosing Cholangitis
- What is being tested?
- Endoscopic retrograde Cholangio- pancreatography and Endoscopic ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2022to 14 Jan 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients eligible for endoscopic procedures at Karolinska University Hospital
Who may be able to join
- Clinical indication for endoscopic intervention/procedure
Who cannot join
- No informed consent
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 18146
Erik von Seth, MD, PhD, +46812380000, erik.von.seth@ki.se
About this study
Official title: Research Registry for Endoscopic Treatment and Diagnostics
Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract
- Being tested
- Endoscopic retrograde Cholangio- pancreatography, Endoscopic ultrasound
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde Cholangio- pancreatographyProcedure or surgery
Endoscopic intervention in the biliary or pancreatic duct
Endoscopic ultrasoundProcedure or surgery
Endoscopic investigation/intervention with ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of Adverse events following endoscopic procedures. Measured as percentage of individuals with an adverse event
Measured: 30-days and 60-days post-procedure
Diagnostic yield
Diagnostic yield after tissue sampling
Measured: 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start14 Jan 2022
- Primary completion14 Jan 2032 (estimated)
- Study completion14 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies 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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Erik von Seth, MD, PhD, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187312
- Sponsor's protocol ID
- 2021-7616
- Acronym
- ERDB
- Status last verified
- Apr 2024
- First submitted
- 25 Dec 2021
- Last updated
- 12 Apr 2024
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Registry for Endoscopic Treatment and Diagnostics
- ClinicalTrials.gov ID
- NCT05187312
- Acronym / sponsor ID
- ERDB / 2021-7616
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 14 Jan 2032 (estimated)
- Study completion
- 14 Jan 2032 (estimated)
- First posted
- 11 Jan 2022 (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.
Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for endoscopic procedures at Karolinska University Hospital
Key inclusion criteria (1 listed)
- Clinical indication for endoscopic intervention/procedure
Key exclusion criteria (2 listed)
- No informed consent
- Age <18 years
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 retrograde Cholangio- pancreatographyEndoscopic intervention in the biliary or pancreatic duct | Procedure or surgery | – |
| Endoscopic ultrasoundEndoscopic investigation/intervention with ultrasound | Procedure or surgery | – |
Primary outcome
Adverse events
Time frame: 30-days and 60-days post-procedure
Incidence of Adverse events following endoscopic procedures. Measured as percentage of individuals with an adverse event
Diagnostic yield
Time frame: 1-year follow up
Diagnostic yield after tissue sampling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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.
Erik von Seth, MD, PhD principal investigator
Region Stockholm
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 Cholangiocarcinoma and Pancreatic Cancer, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Apr 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik von Seth, MD, PhD (+46812380000, erik.von.seth@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 30-days and 60-days post-procedure). The study lists 2 primary outcomes in all. 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 12 Apr 2024.