ERCP TrainingNCT06197815
Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP
A study testing The assistance type during ERCP in people with ERCP Training, run by Air Force Military Medical University, China at 3 sites in China.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skill and at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- ERCP Training
- What is being tested?
- The assistance type during ERCP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 3 sitesChina
- Study dates
- 3 Dec 2020to Aug 2024
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-90 years who received ERCP
- Patients with native papilla
Who cannot join
- Patients with altered anatomy (Billroth I/II, Roux-en-Y)
- Type II duodenal stenosis
- Previously failed cannulation
- Chronic pancreatitis with stones in the pancreatic head
- Hemodynamic instability
- Lactating or pregnant women
- Inability to give written informed consent
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Bo Ning, MD, 13996476336, ningbo.bo@163.com
- Recruiting
Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 201823
Mingxing Xia, MD, 13906524284, xiamingxing1982@126.com
- Recruiting
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Yanglin Pan, MD, 86-29-84771536, yanglinpan@hotmail.com
About this study
Official title: Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skill and at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. It required the trainer to stand by the trainee in the procedure room to assist. There were insufficient patients for most trainees to achieve competence until the trainee graduate. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. We hypothesized that the trainee can be safely guided by a senior trainer off-site with the endoscopic view displayed on a screen. Using the teleguidance, the trainer can even continue to provide guidance when the trainees complete their training and return to their hospitals until they achieve the recommended clinical competency. Given the advantages of the off-site teleguidance, it could be an attractive substitute for hands-on assistance to ERCP training.
The primary aim of this study was to evaluate whether off-site assistance (OA group) could achieve a comparable success rate to standard hands-on assistance (HA group) with regard to the rates of successful selective biliary cannulation during ERCP training.
- Conditions
- ERCP Training
- Being tested
- The assistance type during ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The assistance type during ERCPBehavioural
The senior trainer guides the trainees during ERCP procedure outside the operating room using communication equipment and the screen displaying an endoscopic view.
| Study group | Role | What they receive |
|---|---|---|
| Off-site assistance group | Experimental | The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic view. Trainees wear headphones, and trainers use intercom to provide the unlimited verbal instructions. The trainer was not allowed into the procedure room and touched the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. Then the trainer would then take over and continue with the cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Receives: Behavioral: The assistance type during ERCP |
| Hands-on assistance group | Active comparator | During trainees' attempted cannulation, the trainer gave unlimited verbal instructions with hands-on assistance limited to only adjustment of scope position if necessary. To avoid unintended cannulation, the trainer was not allowed to touch the control section of the scope or the sphincterotome used for cannulation. However, the trainer would correct any inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. The trainees could ask for help or stop cannulation at any time if they were not comfortable continuing the procedure. The trainer would then take over and continue with the cannulation. Receives: Behavioral: The assistance type during ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of successful biliary cannulation
The percentage of trainee successfully biliary cannulation
Measured: 10 minutes
Secondary outcomes (4)
Cannulation time
Measured: 1 day
Competency score from the trainer and endoscopic video
Measured: 1 day
Incidences of PEP and other adverse events
Measured: 1 month
Ionizing radiation time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start3 Dec 2020
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCP TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 754 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University, The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197815
- Sponsor's protocol ID
- KY20232429
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study
- ClinicalTrials.gov ID
- NCT06197815
- Acronym / sponsor ID
- KY20232429
- Conditions
- ERCP Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 754 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University, The Second Affiliated Hospital of Chongqing Medical University
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Jan 2024 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skill and at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. It required the trainer to stand by the trainee in the procedure room to assist. There were insufficient patients for most trainees to achieve competence until the trainee graduate. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. We hypothesized that the trainee can be safely guided by a senior trainer off-site with the endoscopic view displayed on a screen. Using the teleguidance, the trainer can even continue to provide guidance when the trainees complete their training and return to their hospitals until they achieve the recommended clinical competency. Given the advantages of the off-site teleguidance, it could be an attractive substitute for hands-on assistance to ERCP training.
The primary aim of this study was to evaluate whether off-site assistance (OA group) could achieve a comparable success rate to standard hands-on assistance (HA group) with regard to the rates of successful selective biliary cannulation during ERCP training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-site assistance group | Experimental | Behavioral: The assistance type during ERCPThe trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic view. Trainees wear headphones, and trainers use intercom to provide the unlimited verbal instructions. The trainer was not allowed into the procedure room and touched the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. Then the trainer would then take over and continue with the cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. |
| Hands-on assistance group | Active comparator | Behavioral: The assistance type during ERCPDuring trainees' attempted cannulation, the trainer gave unlimited verbal instructions with hands-on assistance limited to only adjustment of scope position if necessary. To avoid unintended cannulation, the trainer was not allowed to touch the control section of the scope or the sphincterotome used for cannulation. However, the trainer would correct any inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. The trainees could ask for help or stop cannulation at any time if they were not comfortable continuing the procedure. The trainer would then take over and continue with the cannulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-90 years who received ERCP
- Patients with native papilla
Key exclusion criteria (7 listed)
- Patients with altered anatomy (Billroth I/II, Roux-en-Y)
- Type II duodenal stenosis
- Previously failed cannulation
- Chronic pancreatitis with stones in the pancreatic head
- Hemodynamic instability
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 |
|---|---|---|
| The assistance type during ERCPThe senior trainer guides the trainees during ERCP procedure outside the operating room using communication equipment and the screen displaying an endoscopic view. | Behavioural | Hands-on assistance group, Off-site assistance group |
Primary outcome
Rates of successful biliary cannulation
Time frame: 10 minutes
The percentage of trainee successfully biliary cannulation
4 secondary outcomes
Cannulation time
Time frame: 1 day
Competency score from the trainer and endoscopic video
Time frame: 1 day
Incidences of PEP and other adverse events
Time frame: 1 month
Ionizing radiation time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for ERCP Training
Not yet recruiting
SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0
Biliary Tract Diseases, Pancreatic Diseases
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The assistance type during ERCP in people with ERCP Training, run by Air Force Military Medical University, China at 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, MD (86-29-84771536, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of successful biliary cannulation (time frame: 10 minutes). 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 17 Jan 2024.