Post-ERCP Acute PancreatitisNCT03771547
ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events
An observational study of Post-ERCP Acute Pancreatitis and Cholangitis, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Today 11 percent of China's population is over the age of 65, and according to United Nations, it will take China just 20 years for the proportion of the elderly population to double to 25%. Read more about this study
- Who is it for?
- Ages 16 to 94 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis, Cholangitis
- What is being tested?
- ERCP
- How many people
- 614 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 1 Mar 2018
- How long will I take part?
- 30 Days
- 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 16 to 94 years
- All sexes
- Child, Adult, Older adult
Study population: No specific restrictions on selecting the patients.
Who may be able to join
- Patients who underwent ERCP between July 2016 and January 2018.
Who cannot join
- We excluded the patients who underwent ERCP for the objectives of follow up, stent removing or taking a biopsy.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
About this study
Today 11 percent of China's population is over the age of 65, and according to United Nations, it will take China just 20 years for the proportion of the elderly population to double to 25%. As life expectancy has increased, application of Endoscopic Retrograde Cholangiopancreatography (ERCP) in super-aged (≥80 years of age) is no longer limited with increasing prevalence of choledocholithiasis, and malignancy in advancing age. This increasing may come with more difficulty in cannulation or more complications in senior patients. Regarding difficult cannulation, little is known about grading difficulty in the elderly and its relation with adverse events. Therefore, it is time to evaluate the risk factors of adverse events in super-aged patients with difficult bile duct cannulation.
Read the detailed description
AIM: To evaluate the incidence, causes, and management of difficult biliary cannulation during ERCP in elderly patients and its role as a risk factor for adverse events.
METHODS: A total of 614 patients, with a mean age of 65.3±16.7 years, underwent ERCP during the study period, were prospectively managed and divided into two groups based on their age. There were 146 patients aged 80 years or older in group A with the mean age of 84±3.4 years. The primary outcome measurements were the difficulty grade of papilla cannulation, clinical outcomes, and ERCP-related complications in the two groups. The adverse events were analyzed by logistic regression about patient age, co-morbidities, indications, and difficult cannulation grading.
- Conditions
- Post-ERCP Acute Pancreatitis, Cholangitis
- Being tested
- ERCP
- Keywords
- ERCP, Elderly, Difficult cannulation
- Medical subject headings
- Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| More 80 | The first group included ERCP patients aged 80 and above. Receives: Diagnostic Test: ERCP | |
| Less 80 | The second group included those ERCP patients younger than 80. Receives: Diagnostic Test: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events in difficult cannulation patients
Multi-variate regression will be used to check the risk factors of adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Jul 2016
- Primary completion30 Jan 2018
- Study completion1 Mar 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 Post-ERCP Acute PancreatitisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 614 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Miao, PhD, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771547
- Sponsor's protocol ID
- DC-0918
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tabak F, Ji GZ, Miao L. Impact of periampullary diverticulum on biliary cannulation and ERCP outcomes: a single-center experience. Surg Endosc. 2021 Nov;35(11):5953-5961. doi: 10.1007/s00464-020-08080-8. Epub 2020 Oct 7.
PubMed 33029732
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events
- ClinicalTrials.gov ID
- NCT03771547
- Acronym / sponsor ID
- DC-0918
- Conditions
- Post-ERCP Acute Pancreatitis, Cholangitis
- Keywords
- ERCP, Elderly, Difficult cannulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 11 Dec 2018 (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.
Today 11 percent of China's population is over the age of 65, and according to United Nations, it will take China just 20 years for the proportion of the elderly population to double to 25%. As life expectancy has increased, application of Endoscopic Retrograde Cholangiopancreatography (ERCP) in super-aged (≥80 years of age) is no longer limited with increasing prevalence of choledocholithiasis, and malignancy in advancing age. This increasing may come with more difficulty in cannulation or more complications in senior patients. Regarding difficult cannulation, little is known about grading difficulty in the elderly and its relation with adverse events. Therefore, it is time to evaluate the risk factors of adverse events in super-aged patients with difficult bile duct cannulation.
Detailed description
AIM: To evaluate the incidence, causes, and management of difficult biliary cannulation during ERCP in elderly patients and its role as a risk factor for adverse events.
METHODS: A total of 614 patients, with a mean age of 65.3±16.7 years, underwent ERCP during the study period, were prospectively managed and divided into two groups based on their age. There were 146 patients aged 80 years or older in group A with the mean age of 84±3.4 years. The primary outcome measurements were the difficulty grade of papilla cannulation, clinical outcomes, and ERCP-related complications in the two groups. The adverse events were analyzed by logistic regression about patient age, co-morbidities, indications, and difficult cannulation grading.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| More 80 | – | Diagnostic Test: ERCPThe first group included ERCP patients aged 80 and above. |
| Less 80 | – | Diagnostic Test: ERCPThe second group included those ERCP patients younger than 80. |
Who may qualify
- Ages
- 16 to 94 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- No specific restrictions on selecting the patients.
Key inclusion criteria (1 listed)
- Patients who underwent ERCP between July 2016 and January 2018.
Key exclusion criteria (1 listed)
- We excluded the patients who underwent ERCP for the objectives of follow up, stent removing or taking a biopsy.
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 |
|---|---|---|
| ERCP | Diagnostic test | Less 80, More 80 |
Primary outcome
Adverse events in difficult cannulation patients
Time frame: 30 days
Multi-variate regression will be used to check the risk factors of adverse events
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 11 Dec 2018.
- Derived from this study: PubMed 33029732Tabak F, Ji GZ, Miao L. Impact of periampullary diverticulum on biliary cannulation and ERCP outcomes: a single-center experience. Surg Endosc. 2021 Nov;35(11):5953-5961. doi: 10.1007/s00464-020-08080-8. Epub 2020 Oct 7.
- Individual participant dataSharing planned: Undecided
Related trials for Post-ERCP Acute Pancreatitis
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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.
Lin Miao, PhD principal investigator
Nanjing Medical University
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 Post-ERCP Acute Pancreatitis and Cholangitis, run by The Second Hospital of Nanjing Medical University 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: finished, as of the sponsor's last update on 11 Dec 2018. 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?
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?
Adverse events in difficult cannulation patients (time frame: 30 days). 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 NCT03771547, 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 11 Dec 2018; AzTrials last refreshed its copy on 28 Oct 2026.