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NCT Number: NCT07568626

Factors for Prolonged Hospital Stays in Patients Undergoing ERCP

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiamen Hong'ai Hospital, Xiamen, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age ≥ 65 years
  • Scheduled to undergo ERCP procedure

Exclusion criteria

  • Severe cognitive dysfunction
  • Severe hearing impairment
  • Known or suspected gastrointestinal perforation
  • Hemodynamic instability
  • Pregnant or lactating women
  • Unable to sign the informed consent form

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of total adverse events

    Time frame: 30 days

    Adverse events include ERCP-related or non ERCP-related adverse events

  2. Total Length of Hospital Stay

    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.

  3. Post-procedure Length of Hospital Stay

    Time frame: 30 days

    The number of days from the day of the ERCP procedure to hospital discharge

  4. Rate of post-ERCP Pancreatitis

    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.

  5. Rate of ERCP-related bleeding

    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.

  6. Rate of ERCP-related perforation

    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.

  7. Rate of ERCP-related infection

    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.

  8. Total Hospitalization Costs

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanglin Pan, M.D

CONTACT

[email protected]

13991811225

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Factors Associated With Prolonged Hospital Stay in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective, Multicenter Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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