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Frailty check could predict oxygen danger during ERCP in seniors

NCT ID NCT07568912

Knowledge-focused Sponsor: China-Japan Friendship Hospital Source: ClinicalTrials.gov ↗

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This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether being frail increases the risk of dangerously low oxygen levels during a procedure called ERCP in people aged 65 and older. Researchers will assess frailty before the procedure and track oxygen levels during it. The goal is to create a simple tool that helps doctors predict and prevent this complication, making the procedure safer for older patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 701 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This observational cohort study will enroll elderly patients aged 65 years and older who are scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP) under anesthesia sedation at China-Japan Friendship Hospital. The study population consists of two sequential cohorts: a retrospective cohort of 313 patients with complete electronic health record data and a prospective cohort of 388 patients to be recruited prospectively. Eligible participants include those with American Society of Anesthesiologists (ASA) physical status II-IV and an expected procedure duration of less than 60 minutes, with adequate intraoperative pulse oximetry monitoring.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 65 years or older 2. Elective endoscopic retrograde cholangiopancreatography (ERCP) under anesthesia sedation 3. American Society of Anesthesiologists (ASA) physical status II-IV 4. Expected procedure duration less than 60 minutes 5. Available and complete intraoperative pulse oximetry (SpO₂) monitoring data Exclusion Criteria: 1. Emergency ERCP 2. Severe anemia (hemoglobin \< 60 g/L) or conditions interfering with accurate 3. SpO₂ measurement 4\. Pre-existing severe respiratory insufficiency requiring long-term oxygen therapy 5. Unstable hemodynamics requiring continuous vasopressor infusion Impaired consciousness, delirium, or cognitive dysfunction that prevents reliable frailty assessment

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoxemia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.