Indomethacin for Biliary ERCP Patients
NCT07661498
Digestive System Diseases, Pancreatic Diseases
San Francisco, California, United States
View Trial DetailsNCT Number: NCT07568626
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.
Interested in participating?
Request Info65 year and older
All sexes
Observational
Xiamen Hong'ai Hospital, Xiamen, Fujian, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days
Adverse events include ERCP-related or non ERCP-related adverse events
Time frame: 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.
Time frame: 30 days
The number of days from the day of the ERCP procedure to hospital discharge
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Air Force Military Medical University, China
Other
Factors Associated With Prolonged Hospital Stay in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective, Multicenter Cohort Study
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NCT07661498
Digestive System Diseases, Pancreatic Diseases
San Francisco, California, United States
View Trial Details