Duodenal Papilla, MajorKappaIINCT02883608
Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
A study testing cap assisted forward-viewing endoscope in people with Duodenal Papilla, Major, run by Technical University of Munich at 1 site in Germany.
Trial summary
Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Duodenal Papilla, Major
- What is being tested?
- cap assisted forward-viewing endoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to 22 Jan 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for elective upper endoscopy
- age over 18 years
- ability to provide informed consent
Who cannot join
- surgically altered upper gastrointestinal tract
- known or suspected upper gastrointestinal strictures
- upper gastrointestinal bleeding
- biliary stent
- planned endoscopic intervention
- American Society of Anesthesiologists class III or higher
- contraindication for or refusal of sedation with Propofol
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side*viewing duodenoscope for complete examination of MDP.
- Conditions
- Duodenal Papilla, Major
- Being tested
- cap assisted forward-viewing endoscope
- Keywords
- Papilla, major duodenal papilla, ampulla of vater
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cap assisted forward-viewing endoscopeProcedure or surgery
a cap fitted to the to top of the forward-viewing endoscope
| Study group | Role | What they receive |
|---|---|---|
| Initial cap assisted endoscopy | Experimental | undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope Receives: Procedure: cap assisted forward-viewing endoscope |
| Initial standard endoscopy | Active comparator | undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope Receives: Procedure: cap assisted forward-viewing endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete visualisation of papilla duodeni major
complete visualization is defined by visualization of both proximal and distal ends together with the orifice of the papilla
Measured: within 5 minutes after intubation of the esophagus
Secondary outcomes (1)
Duration needed to localize the papilla
Measured: within 5 minutes after intubation of the esophagus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completion22 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duodenal Papilla, MajorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelhafez, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883608
- Sponsor's protocol ID
- 216/16 s
- Acronym
- KappaII
- Status last verified
- May 2017
- First submitted
- 21 Aug 2016
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abdelhafez M, Phillip V, Hapfelmeier A, Sturm V, Elnegouly M, Dollhopf M, Kassem A, Klare P, Nennstiel S, Schmid RM, von Delius S, Eckel F. Comparison of cap-assisted endoscopy vs. side-viewing endoscopy for examination of the major duodenal papilla: a randomized, controlled, noninferiority crossover study. Endoscopy. 2019 May;51(5):419-426. doi: 10.1055/a-0662-5445. Epub 2018 Sep 10.
PubMed 30199900
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
- ClinicalTrials.gov ID
- NCT02883608
- Acronym / sponsor ID
- KappaII / 216/16 s
- Conditions
- Duodenal Papilla, Major
- Keywords
- Papilla, major duodenal papilla, ampulla of vater
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- 22 Jan 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side*viewing duodenoscope for complete examination of MDP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial cap assisted endoscopy | Experimental | Procedure: cap assisted forward-viewing endoscopeundergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope |
| Initial standard endoscopy | Active comparator | Procedure: cap assisted forward-viewing endoscopeundergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for elective upper endoscopy
- age over 18 years
- ability to provide informed consent
Key exclusion criteria (8 listed)
- surgically altered upper gastrointestinal tract
- known or suspected upper gastrointestinal strictures
- upper gastrointestinal bleeding
- biliary stent
- planned endoscopic intervention
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 |
|---|---|---|
| cap assisted forward-viewing endoscopea cap fitted to the to top of the forward-viewing endoscope | Procedure or surgery | Initial cap assisted endoscopy, Initial standard endoscopy |
Primary outcome
Rate of complete visualisation of papilla duodeni major
Time frame: within 5 minutes after intubation of the esophagus
complete visualization is defined by visualization of both proximal and distal ends together with the orifice of the papilla
1 secondary outcome
Duration needed to localize the papilla
Time frame: within 5 minutes after intubation of the esophagus
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 23 May 2017.
- Derived from this study: PubMed 30199900Abdelhafez M, Phillip V, Hapfelmeier A, Sturm V, Elnegouly M, Dollhopf M, Kassem A, Klare P, Nennstiel S, Schmid RM, von Delius S, Eckel F. Comparison of cap-assisted endoscopy vs. side-viewing endoscopy for examination of the major duodenal papilla: a randomized, controlled, noninferiority crossover study. Endoscopy. 2019 May;51(5):419-426. doi: 10.1055/a-0662-5445. Epub 2018 Sep 10.
- 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?
A study testing cap assisted forward-viewing endoscope in people with Duodenal Papilla, Major, run by Technical University of Munich 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 8 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 23 May 2017. 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?
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 complete visualisation of papilla duodeni major (time frame: within 5 minutes after intubation of the esophagus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883608, which also lists 1 linked publication.
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 23 May 2017.