Post-ERCP Adverse EventsNCT07568626
Factors for Prolonged Hospital Stays in Patients Undergoing ERCP
An observational study of Post-ERCP Adverse Events and ERCP Complications, run by Air Force Military Medical University, China at 5 sites in China.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a crucial minimally invasive technique for the diagnosis and treatment of biliary and pancreatic diseases. However, it remains technically demanding and carries a postoperative adverse event (AE) rate exceeding 10% (e.g., pancreatitis, bleeding, and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Post-ERCP Adverse Events, ERCP Complications
- How many people
- 504 participants
- Where
- 5 sitesChina
- Study dates
- 15 Feb 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged ≥ 65 years old who are scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) are eligible for our study.
Who may be able to join
- Patient age ≥ 65 years
- Scheduled to undergo ERCP procedure
Who cannot join
- Severe cognitive dysfunction
- Severe hearing impairment
- Known or suspected gastrointestinal perforation
- Hemodynamic instability
- Pregnant or lactating women
- Unable to sign the informed consent form
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710000
Yanglin Pan, M.D, 13991811225, yanglinpan@hotmail.com
- Recruiting
The Second Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710038
Zhenxiong Liu, M.D, 13572276166, liuzhx816@126.com
- Recruiting
Department of Gastroenterology, 986 Hospital of Xijing Hospital, Fourth MilitaryMedical University
Xi'an, Shaanxi, 710054
Jun Wang, M.D, 86-29-84734201, Wangjundoctor@aliyun.com
- Recruiting
Xi'an Honghui Hospital
Xi'an, Shaanxi, 710054
Yupeng Shi, M.M, 13891893748, xjshiyupeng@163.com
- Recruiting
Xiamen Hong'ai Hospital
Xiamen, Fujian, 361009
Rongchun Zhang, M.D, 15829395908, zrc.700502@163.com
About this study
Official title: Factors Associated With Prolonged Hospital Stay in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective, Multicenter Cohort Study
Endoscopic retrograde cholangiopancreatography (ERCP) is a crucial minimally invasive technique for the diagnosis and treatment of biliary and pancreatic diseases. However, it remains technically demanding and carries a postoperative adverse event (AE) rate exceeding 10% (e.g., pancreatitis, bleeding, and perforation), which subsequently leads to prolonged length of stay (LOS) and increased healthcare costs. With the rapid acceleration of population aging, the clinical demand for ERCP among the elderly has surged. Although ERCP is generally considered safe for older adults, advanced age also increases the risk of ERCP-related AEs and prolonged LOS. While previous studies investigated the outcomes of ERCP in elderly patients, those studies were predominantly retrospective, accompanied by selection bias. Moreover, insufficient factors were included in those retrospective studies. Importantly, some aging-related parameters, such as frailty, functional reserve, cognitive and psychological status, were not included in previous studies. Therefore, the investigators conducted a prospective, multicenter cohort study aimed at investigating outcomes in elderly patients undergoing ERCP and comprehensive factors (patient-related, procedure-related, and geriatric factors) associated with adverse outcomes.
- Conditions
- Post-ERCP Adverse Events, ERCP Complications
- Keywords
- Elderly, Length of Stay, Adverse Events, ERCP
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Postoperative Length of Stay
A binary outcome defined as a postoperative length of stay > 5 days. It is calculated as the duration from the completion of the ERCP procedure to the date of formal hospital discharge.
Measured: 30 days
Secondary outcomes (8)
Rate of total adverse events
Adverse events include ERCP-related or non ERCP-related adverse events
Measured: 30 days
Total Length of Hospital Stay
Total length of stay (TLOS), defined as the total duration in days from the date of hospital admission to the date of hospital discharge.
Measured: 30 days
Post-procedure Length of Hospital Stay
The number of days from the day of the ERCP procedure to hospital discharge
Measured: 30 days
Rate of post-ERCP Pancreatitis
a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus.
Measured: 30 days
Rate of ERCP-related bleeding
Bleeding was established according to Cotton criteria. Mild: a documented decrease in hemoglobin concentration by <3 g/L, without requiring the blood transfusion; Moderate: blood transfusion ≤ 4 units; without need for angiographic or surgery interventions ;Severe: Transfusion: ≥ 5 units or requiring for angiographic or surgery interventions.
Measured: 30 days
Rate of ERCP-related perforation
Perforation was established according to Cotton criteria.Mild: slight leakage of fluid or contrast dye, manageable through fluid administration and suction therapy 3 days; Moderate: definite perforation required to be managed for 4-10 days; Severe: management for more than 10 days or requiring for percutaneous or surgical intervention.
Measured: 30 days
Rate of ERCP-related infection
Infection was established according to Cotton criteria.Mild: temperature >38℃ for 24-48h; Moderate: Febrile illness requiring >3 days of hospital treatment; endoscopic or percutaneous interventions; Severe: septic shock or requiring surgery.
Measured: 30 days
Total Hospitalization Costs
The sum of all medical expenses incurred during the entire hospitalization, denominated in Chinese Yuan (CNY). This includes costs for medication, laboratory and imaging tests, treatments, procedures, surgical operations, medical supplies, and bed occupancy.
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 posted6 May 2026
- Study start15 Feb 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Adverse EventsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 504 participants (estimated)
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
- NCT07568626
- Sponsor's protocol ID
- KY20252608-C-1
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Prolonged Hospital Stay in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07568626
- Acronym / sponsor ID
- KY20252608-C-1
- Conditions
- Post-ERCP Adverse Events, ERCP Complications
- Keywords
- Elderly, Length of Stay, Adverse Events, ERCP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 May 2026 (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 crucial minimally invasive technique for the diagnosis and treatment of biliary and pancreatic diseases. However, it remains technically demanding and carries a postoperative adverse event (AE) rate exceeding 10% (e.g., pancreatitis, bleeding, and perforation), which subsequently leads to prolonged length of stay (LOS) and increased healthcare costs. With the rapid acceleration of population aging, the clinical demand for ERCP among the elderly has surged. Although ERCP is generally considered safe for older adults, advanced age also increases the risk of ERCP-related AEs and prolonged LOS. While previous studies investigated the outcomes of ERCP in elderly patients, those studies were predominantly retrospective, accompanied by selection bias. Moreover, insufficient factors were included in those retrospective studies. Importantly, some aging-related parameters, such as frailty, functional reserve, cognitive and psychological status, were not included in previous studies. Therefore, the investigators conducted a prospective, multicenter cohort study aimed at investigating outcomes in elderly patients undergoing ERCP and comprehensive factors (patient-related, procedure-related, and geriatric factors) associated with adverse outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥ 65 years old who are scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) are eligible for our study.
Key inclusion criteria (2 listed)
- Patient age ≥ 65 years
- Scheduled to undergo ERCP procedure
Key exclusion criteria (6 listed)
- Severe cognitive dysfunction
- Severe hearing impairment
- Known or suspected gastrointestinal perforation
- Hemodynamic instability
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prolonged Postoperative Length of Stay
Time frame: 30 days
A binary outcome defined as a postoperative length of stay > 5 days. It is calculated as the duration from the completion of the ERCP procedure to the date of formal hospital discharge.
8 secondary outcomes
Rate of total adverse events
Time frame: 30 days
Total Length of Hospital Stay
Time frame: 30 days
Post-procedure Length of Hospital Stay
Time frame: 30 days
Rate of post-ERCP Pancreatitis
Time frame: 30 days
Rate of ERCP-related bleeding
Time frame: 30 days
Rate of ERCP-related perforation
Time frame: 30 days
Rate of ERCP-related infection
Time frame: 30 days
Total Hospitalization Costs
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites 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 Adverse Events and ERCP Complications, run by Air Force Military Medical University, China at 5 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 6 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, M.D (13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Postoperative Length of Stay (time frame: 30 days). 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 14 Jul 2026.