ERCPNCT03350555
Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
A study testing Additioned Endoscopy in people with ERCP, run by Changhai Hospital at 1 site in China.
Trial summary
Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ERCP
- What is being tested?
- Additioned Endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2017to Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who are indicated to ERCP treatment.
Who cannot join
- People who are not suitable for ERCP treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
About this study
Official title: Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.
Read the detailed description
Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.
- Conditions
- ERCP
- Being tested
- Additioned Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additioned EndoscopyDevice
To evaluate the use of additioned endoscopy in ERCP treatment.
| Study group | Role | What they receive |
|---|---|---|
| ERCP with additioned endoscopy | Experimental | This arm will include participants undergoing ERCP with assistance of additioned endoscopy. Receives: Device: Additioned Endoscopy |
| ERCP without additioned endoscopy | No intervention | This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of ERCP treatment
To test if additioned endoscopy will have impact on duration of ERCP treatment
Measured: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient
Secondary outcomes (1)
complications of ERCP treatment
To test if additioned endoscopy will have impact on incidence of ERCP complications, including perforation, bleeding, post-ERCP pancreatitis.
Measured: up to 1 month after ERCP completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study startNov 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyu Kong, Changhai Hospital
- Investigators
- Zhaoshen Li, MD, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350555
- Sponsor's protocol ID
- Additioned Endocopy in ERCP
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 22 Nov 2017
- 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 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT03350555
- Acronym / sponsor ID
- Additioned Endocopy in ERCP
- Conditions
- ERCP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Nov 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.
Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.
Detailed description
Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.
| Arm | Type | Receives |
|---|---|---|
| ERCP with additioned endoscopy | Experimental | Device: Additioned EndoscopyThis arm will include participants undergoing ERCP with assistance of additioned endoscopy. |
| ERCP without additioned endoscopy | No intervention | –This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who are indicated to ERCP treatment.
Key exclusion criteria (1 listed)
- People who are not suitable for ERCP treatment.
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 |
|---|---|---|
| Additioned EndoscopyTo evaluate the use of additioned endoscopy in ERCP treatment. | Device | ERCP with additioned endoscopy |
Primary outcome
Duration of ERCP treatment
Time frame: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient
To test if additioned endoscopy will have impact on duration of ERCP treatment
1 secondary outcome
complications of ERCP treatment
Time frame: up to 1 month after ERCP completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for ERCP
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
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.
Zhaoshen Li, MD study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additioned Endoscopy in people with ERCP, run by Changhai Hospital at 1 site 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 1 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 22 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangyu Kong, MD (13564644397, xiaoniu185@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of ERCP treatment (time frame: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient). 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 Nov 2017.