ERCP Complications, Post-ERCP Adverse Events
Conditions
Keywords
Elderly, Length of Stay, Adverse Events, ERCP
Brief 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 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.
Interventions
None listed
Sponsors
Air Force Military Medical University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age ≥ 65 years 2. Scheduled to undergo ERCP procedure
Exclusion criteria
1. Severe cognitive dysfunction 2. Severe hearing impairment 3. Known or suspected gastrointestinal perforation 4. Hemodynamic instability 5. Pregnant or lactating women 6. Unable to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Postoperative Length of Stay | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ERCP-related perforation | 30 days | 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. |
| Rate of ERCP-related infection | 30 days | 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. |
| Total Hospitalization Costs | 30 days | 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. |
| Rate of total adverse events | 30 days | Adverse events include ERCP-related or non ERCP-related adverse events |
| Total Length of Hospital Stay | 30 days | Total length of stay (TLOS), defined as the total duration in days from the date of hospital admission to the date of hospital discharge. |
| Post-procedure Length of Hospital Stay | 30 days | The number of days from the day of the ERCP procedure to hospital discharge |
| Rate of ERCP-related bleeding | 30 days | 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. |
| Rate of post-ERCP Pancreatitis | 30 days | 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. |
Countries
China
Contacts
CONTACTYanglin Pan, M.D
Outcome results
None listed