Observation of Major Duodenal Papilla (MDP)NCT03219619
Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla
A study testing Cap-EGD and Duo in people with Observation of Major Duodenal Papilla (MDP), run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Observation of Major Duodenal Papilla (MDP)
- What is being tested?
- Cap-EGD and Duo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2018to 20 Jul 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 70 years
- Patients with native MDP who underwent ERCP
Who cannot join
- Prior surgery in upper GI tract
- Prior history of endoscopic sphincterotomy
- Prior history of MDP treatment
- Known or suspected obstruction of upper GI tract
- Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
- Pregnancy or lactic women
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla: a Randomized Non-inferiority Trial
Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.
Read the detailed description
Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.
- Being tested
- Cap-EGD, Duo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap-EGDDevice
Undergoing cap-assisted endoscopy
DuoDevice
Undergoing side-viewing duodenoscope
| Study group | Role | What they receive |
|---|---|---|
| Cap group: Cap-EGD | Experimental | Undergoing cap-assisted esophagogastroduodenoscopy Receives: Device: Cap-EGD |
| Duo group: Duo | Active comparator | Undergoing side-viewing duodenoscope Receives: Device: Duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete examination of MDP
Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla
Measured: 5 minutes after intubation of the esophagus
Secondary outcomes (4)
Endoscopic findings in descending duodenum
All pathological findings which are seen in descending duodenum should be reported (e.g. ampullary adenoma, peripapillary diverticulum, ampullary carcinoma, inflammatory change of papilla, etc)
Measured: 5 minutes after intubation of the esophagus
Overall endoscopic findings
All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, gastric cancer, gastric ulcer, duodenal ulcer, etc)
Measured: 5 minutes after intubation of the esophagus
MDP examination time
The times taken for the examination of the MDP (after passing the pylorus until examination of MDP)
Measured: 5 minutes after intubation of the esophagus
MDP examination score
Score 3 when proximal end, distal end and orifice were visualized; Score 2 when either proximal or distal end with orifice were visualized; Score 1 when either proximal or distal end without orifice was visualized; Score 0 when the MDP could not be localized
Measured: 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 posted17 Jul 2017
- Study start20 Jul 2018
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
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 Observation of Major Duodenal Papilla (MDP)Studies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219619
- Sponsor's protocol ID
- KY20170517-3
- Status last verified
- Oct 2019
- First submitted
- 13 Jul 2017
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi X, Luo H, Ning B, Wang X, Tao Q, Liang S, Zhang R, Chen J, Luo B, Yao S, Pan Y, Guo X, Fan D. Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial. Endoscopy. 2019 May;51(5):427-435. doi: 10.1055/a-0767-6529. Epub 2019 Jan 8.
PubMed 30620948
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla: a Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03219619
- Acronym / sponsor ID
- KY20170517-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 17 Jul 2017 (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.
Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.
Detailed description
Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap group: Cap-EGD | Experimental | Device: Cap-EGDUndergoing cap-assisted esophagogastroduodenoscopy |
| Duo group: Duo | Active comparator | Device: DuoUndergoing side-viewing duodenoscope |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years and < 70 years
- Patients with native MDP who underwent ERCP
Key exclusion criteria (7 listed)
- Prior surgery in upper GI tract
- Prior history of endoscopic sphincterotomy
- Prior history of MDP treatment
- Known or suspected obstruction of upper GI tract
- Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
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-EGDUndergoing cap-assisted endoscopy | Device | Cap group: Cap-EGD |
| DuoUndergoing side-viewing duodenoscope | Device | Duo group: Duo |
Primary outcome
Rate of complete examination of MDP
Time frame: 5 minutes after intubation of the esophagus
Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla
4 secondary outcomes
Endoscopic findings in descending duodenum
Time frame: 5 minutes after intubation of the esophagus
Overall endoscopic findings
Time frame: 5 minutes after intubation of the esophagus
MDP examination time
Time frame: 5 minutes after intubation of the esophagus
MDP examination score
Time frame: 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 22 Oct 2019.
- Derived from this study: PubMed 30620948Shi X, Luo H, Ning B, Wang X, Tao Q, Liang S, Zhang R, Chen J, Luo B, Yao S, Pan Y, Guo X, Fan D. Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial. Endoscopy. 2019 May;51(5):427-435. doi: 10.1055/a-0767-6529. Epub 2019 Jan 8.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cap-EGD and Duo in people with Observation of Major Duodenal Papilla (MDP), run by Air Force Military Medical University, China at 2 sites in China.
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 7 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 examination of MDP (time frame: 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 NCT03219619, 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 22 Oct 2019.