Ercp in Altered AnatomyNCT04912440
Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy
An observational study of Ercp in Altered Anatomy, run by Evangelisches Krankenhaus Düsseldorf at 1 site in Germany.
Trial summary
Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ercp in Altered Anatomy
- What is being tested?
- MSE-ERCP
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2021to Oct 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: Patients with surgically altered upper gastrointestinal anatomy and indication for endoscopic retrograde cholangio-pancreatography
Who may be able to join
- altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
- indication for ERCP with biliary and/or pancreatic indication
- Enteroscopy-assisted ERCP using MSE, at the study center during the study period
Who cannot join
- due to the retrospective design of the study, no exclusion criteria are defined
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evangelisches Krankenhaus
Düsseldorf, 40217
Torsten Beyna, MD, 00492119191605, Torsten.Beyna@evk-duesseldorf.de
Horst Neuhaus, MD
About this study
Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled
Read the detailed description
All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.
Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.
Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.
- Conditions
- Ercp in Altered Anatomy
- Being tested
- MSE-ERCP
- Keywords
- endoscopy, enteroscopy, ercp in altered anatomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSE-ERCPDevice
No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)
| Study group | Role | What they receive |
|---|---|---|
| MSE-ERCP | Group of patients, that received motorized spiral enteroscopy assisted ERCP in altered anatomy at the single study center Receives: Device: MSE-ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of MSE-ERCP
rate of subjects with successfull MSE-assisted ERCP
Measured: intraprocedural
Adverse event rate of MSE-ERCP
rate of adverse events during and early after MSE-ERCP
Measured: 3 days
Secondary outcomes (2)
Success rate of enteroscopy
rate of subjects with successful enteroscopic access to the papilla
Measured: intraprocedural
Procedural duration
overall time for MSE-ERCP (scope in to scope out)
Measured: intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ercp in Altered AnatomyStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Düsseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torsten Beyna, MD PhD, Principal investigator, Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912440
- Sponsor's protocol ID
- EVK-PSE-ERCP RETRO
- Status last verified
- Jun 2021
- First submitted
- 28 May 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No exchange of individual data is planned
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy
- ClinicalTrials.gov ID
- NCT04912440
- Acronym / sponsor ID
- EVK-PSE-ERCP RETRO
- Conditions
- Ercp in Altered Anatomy
- Keywords
- endoscopy, enteroscopy, ercp in altered anatomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Evangelisches Krankenhaus DüsseldorfUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 3 Jun 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.
Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled
Detailed description
All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.
Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.
Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSE-ERCP | – | Device: MSE-ERCPGroup of patients, that received motorized spiral enteroscopy assisted ERCP in altered anatomy at the single study center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with surgically altered upper gastrointestinal anatomy and indication for endoscopic retrograde cholangio-pancreatography
Key inclusion criteria (3 listed)
- altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
- indication for ERCP with biliary and/or pancreatic indication
- Enteroscopy-assisted ERCP using MSE, at the study center during the study period
Key exclusion criteria (1 listed)
- due to the retrospective design of the study, no exclusion criteria are defined
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 |
|---|---|---|
| MSE-ERCPNo interventional study, MSE-ERCP performed within routine treatment, (approved indication of device) | Device | MSE-ERCP |
Primary outcome
Success rate of MSE-ERCP
Time frame: intraprocedural
rate of subjects with successfull MSE-assisted ERCP
Adverse event rate of MSE-ERCP
Time frame: 3 days
rate of adverse events during and early after MSE-ERCP
2 secondary outcomes
Success rate of enteroscopy
Time frame: intraprocedural
Procedural duration
Time frame: intraprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No. No exchange of individual data is planned
Related trials for Ercp in Altered Anatomy
Recruiting
EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)
Biliary Intervention, Altered Anatomy
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.
Torsten Beyna, MD PhD principal investigator
Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy
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 Ercp in Altered Anatomy, run by Evangelisches Krankenhaus Düsseldorf at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 21 Jun 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torsten Beyna, MD PhD (00492119191605, torsten.beyna@evk-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of MSE-ERCP (time frame: intraprocedural). 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 21 Jun 2021.