Endoscopic Retrograde CholangiopancreatographyNCT06277414
a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication
An observational study of Endoscopic Retrograde Cholangiopancreatography, run by The First Affiliated Hospital of University of South China at 1 site in China.
Trial summary
To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- collection of laboratory test results, imaging results and symptoms
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Routine ERCP patients
Who may be able to join
- Routine ERCP patients
Who cannot join
- Unwillingness or inability to consent for the study
- Pregnant women or breastfeeding
- current acute pancreatitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan
Chen Guodong, PhD, 15211450345, Chenguodong@usc.edu.cn
About this study
Official title: Machine Learning for the Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication Risk
To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP
Read the detailed description
To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP based on machine learning
- Being tested
- collection of laboratory test results, imaging results and symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of laboratory test results, imaging results and symptomsOther
collection of laboratory test results, imaging results and symptoms
| Study group | Role | What they receive |
|---|---|---|
| ERCP | The postoperative laboratory test results, imaging results and symptoms were collected Receives: Other: collection of laboratory test results, imaging results and symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Pancreatitis
Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.
Measured: 1 month
Secondary outcomes (4)
Number of Acute PEC(post-ERCP-cholecystitis )
Number of Acute PEC(post-ERCP-cholecystitis )
Measured: 1 month
Number of Participants with Cholangitis
Temperature should be more than 38 celsius degree, chills, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal
Measured: 1 month
Number of Participants with Perforation
Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting
Measured: 1 month
Number of Participants with bile duct stents
If it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of South China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277414
- Sponsor's protocol ID
- 2024ll0204001
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning for the Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication Risk
- ClinicalTrials.gov ID
- NCT06277414
- Acronym / sponsor ID
- 2024ll0204001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of South ChinaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Feb 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.
To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP
Detailed description
To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP based on machine learning
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP | – | Other: collection of laboratory test results, imaging results and symptomsThe postoperative laboratory test results, imaging results and symptoms were collected |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Routine ERCP patients
Key inclusion criteria (1 listed)
- Routine ERCP patients
Key exclusion criteria (3 listed)
- Unwillingness or inability to consent for the study
- Pregnant women or breastfeeding
- current acute pancreatitis
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 |
|---|---|---|
| collection of laboratory test results, imaging results and symptomscollection of laboratory test results, imaging results and symptoms | Other | ERCP |
Primary outcome
Number of Participants with Pancreatitis
Time frame: 1 month
Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.
4 secondary outcomes
Number of Acute PEC(post-ERCP-cholecystitis )
Time frame: 1 month
Number of Participants with Cholangitis
Time frame: 1 month
Number of Participants with Perforation
Time frame: 1 month
Number of Participants with bile duct stents
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
Not yet recruiting
XRAIconnect Image Guidance Software for ERCP Procedures
Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
Recruiting
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Anesthesia, Sedation
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
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 First Affiliated Hospital of University of South China
Hengyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Retrograde Cholangiopancreatography, run by The First Affiliated Hospital of University of South China 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 3 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 26 Feb 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Pancreatitis (time frame: 1 month). 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 26 Feb 2024.