NeoplasmsNCT03504293
The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions
An observational study of Neoplasms and Biliary Stricture, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Biliary Stricture, Biliary Tract Neoplasms
- What is being tested?
- Combinatory EUS and ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2010to 15 Dec 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: Patients with unclear lesions or strictures in the biliary tract
Who may be able to join
- Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up
Who cannot join
- Patients unwilling to participate
- Patients unfit for EUS and ERCP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sahlgrenska EUS ERCP Study
ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.
The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.
Read the detailed description
The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.
The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.
- Being tested
- Combinatory EUS and ERCP
- Keywords
- Endosonography, Endoscopic retrograde choledochography
- Medical subject headings
- Neoplasms, Biliary Tract Neoplasms, Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combinatory EUS and ERCPProcedure or surgery
EUS performed as a supplementary procedure in addition to ERCP
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Overall accuracy of ERCP and EUS
Measured: 12 months post-EUS
Secondary outcomes (1)
Adverse event rate
The number of patients ending up with some type of complication related to ERCP or EUS
Measured: 30 days post-EUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Jan 2010
- Primary completion30 Nov 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hedenström, Sahlgrenska University Hospital
- Investigators
- Riadh Sadik, Ass Prof, Principal investigator, Sahlgrenska University Hospital, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504293
- Sponsor's protocol ID
- EUS-ERCP Study
- Status last verified
- Dec 2020
- First submitted
- 12 Apr 2018
- Last updated
- 22 Dec 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sahlgrenska EUS ERCP Study
- ClinicalTrials.gov ID
- NCT03504293
- Acronym / sponsor ID
- EUS-ERCP Study
- Keywords
- Endosonography, Endoscopic retrograde choledochography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 20 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.
ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.
The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.
Detailed description
The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.
The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.
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
- Patients with unclear lesions or strictures in the biliary tract
Key inclusion criteria (1 listed)
- Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up
Key exclusion criteria (2 listed)
- Patients unwilling to participate
- Patients unfit for EUS and ERCP
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 |
|---|---|---|
| Combinatory EUS and ERCPEUS performed as a supplementary procedure in addition to ERCP | Procedure or surgery | – |
Primary outcome
Diagnostic accuracy
Time frame: 12 months post-EUS
Overall accuracy of ERCP and EUS
1 secondary outcome
Adverse event rate
Time frame: 30 days post-EUS
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 22 Dec 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.
Riadh Sadik, Ass Prof principal investigator
Sahlgrenska University Hospital, Gothenburg
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 Neoplasms and Biliary Stricture, run by Sahlgrenska University Hospital 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: finished, as of the sponsor's last update on 22 Dec 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 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?
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?
Diagnostic accuracy (time frame: 12 months post-EUS). 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 22 Dec 2020.