Ampulla of Vater Intestinal-Type AdenomaPhase 2NCT02867826
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
A Phase 2 study testing Cap in people with Ampulla of Vater Intestinal-Type Adenoma, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Ampulla of Vater Intestinal-Type Adenoma
- What is being tested?
- Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Dec 2017
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cap-assisted endoscopy
- Referral to endoscopic examination of ampulla of Vater
Who cannot join
- Patients with surgically modified anatomy.
- Obstruction of the upper gastrointestinal tract.
- Contra-indication for endoscopy.
- Absence of informed consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Barretos Cancer Hospital
Barretos, São Paulo, 14784400
Denise P Guimarães, MD, PhD, +55 17 33216600 ext. 6777, guimaraes.dp@gmail.com
Denise P Guimarães, MD, PhD
About this study
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.
Read the detailed description
The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.
- Conditions
- Ampulla of Vater Intestinal-Type Adenoma
- Being tested
- Cap
- Keywords
- Endoscopy, Ampulla of Vater, Duodenoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapDevice
Cap-assisted endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Cap-assisted endoscopy | Experimental | forward-viewing endoscope with a Cap attached at the tip Receives: Device: Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization rates of the ampulla of Vater
Measured: Up to 30 minutes during gastrointestinal endoscopy
Secondary outcomes (3)
Rates of complications for both groups.
Measured: Up to 3 hours after upper endoscopy
Additional time required for Cap-assisted endoscopy
Measured: Up to 30 minutes during upper endoscopy
Need for additional sedation required for the Cap-assisted endoscopy.
Measured: Up to 30 minutes during upper endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Ampulla of Vater Intestinal-Type AdenomaStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Peixoto Guimarães, Barretos Cancer Hospital
- Investigators
- Denise P Guimarães, MD, PhD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867826
- Sponsor's protocol ID
- BarretosCH - 20161
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Silva LC, Arruda RM, Botelho PFR, Taveira LN, Giardina KM, de Oliveira MA, Dias J, Oliveira CZ, Fava G, Guimaraes DP. Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients. BMC Gastroenterol. 2020 Jul 9;20(1):214. doi: 10.1186/s12876-020-01361-5.
PubMed 32646369
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
- ClinicalTrials.gov ID
- NCT02867826
- Acronym / sponsor ID
- BarretosCH - 20161
- Conditions
- Ampulla of Vater Intestinal-Type Adenoma
- Keywords
- Endoscopy, Ampulla of Vater, Duodenoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 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.
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.
Detailed description
The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cap-assisted endoscopy | Experimental | Device: Capforward-viewing endoscope with a Cap attached at the tip |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cap-assisted endoscopy
- Referral to endoscopic examination of ampulla of Vater
Key exclusion criteria (4 listed)
- Patients with surgically modified anatomy.
- Obstruction of the upper gastrointestinal tract.
- Contra-indication for endoscopy.
- Absence of informed consent.
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 |
|---|---|---|
| CapCap-assisted endoscopy | Device | Cap-assisted endoscopy |
Primary outcome
Visualization rates of the ampulla of Vater
Time frame: Up to 30 minutes during gastrointestinal endoscopy
3 secondary outcomes
Rates of complications for both groups.
Time frame: Up to 3 hours after upper endoscopy
Additional time required for Cap-assisted endoscopy
Time frame: Up to 30 minutes during upper endoscopy
Need for additional sedation required for the Cap-assisted endoscopy.
Time frame: Up to 30 minutes during upper endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Derived from this study: PubMed 32646369Silva LC, Arruda RM, Botelho PFR, Taveira LN, Giardina KM, de Oliveira MA, Dias J, Oliveira CZ, Fava G, Guimaraes DP. Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients. BMC Gastroenterol. 2020 Jul 9;20(1):214. doi: 10.1186/s12876-020-01361-5.
- Individual participant dataSharing planned: No
Related trials for Ampulla of Vater Intestinal-Type Adenoma
Not yet recruitingObservational study
Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Ampullary Neoplasm, Ampullary Adenoma
Not yet recruiting
Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy
Post-Procedural Complications
Not yet recruiting
Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors
Ampulla of Vater Neoplasms, Ampullary Adenoma
RecruitingObservational study
Duodenal Polyposis Classification in FAP
Duodenum Cancer, Familial Adenomatous Polyposis
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.
Denise P Guimarães, MD, PhD principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cap in people with Ampulla of Vater Intestinal-Type Adenoma, run by Barretos Cancer Hospital at 1 site in Brazil.
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 2 inclusion and 4 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 18 Aug 2016. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Denise P Guimarães, MD, PhD (+551733216600, guimaraes.dp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization rates of the ampulla of Vater (time frame: Up to 30 minutes during gastrointestinal endoscopy). 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 NCT02867826, 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 18 Aug 2016.