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To operate or not? new study for elderly gallstone patients

NCT ID NCT07001423

Disease control Sponsor: Helsinki University Central Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study looks at whether older adults (80+ or 75+ with health issues) benefit more from gallbladder removal surgery or simply monitoring after their bile duct stones are cleared. About 400 participants will be followed for a year to compare deaths, major complications, and return of gallbladder problems. The goal is to find the safest, most effective approach for this age group.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

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

Started

Oct 2025

Expected to finish

Aug 2032

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.

Ages

75 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: * Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP) * Age \>= 80 years or age 75-79 years with a Charlson Comorbidity index \>=2 * gallbladder in situ Exclusion Criteria: * Acute Cholecystitis * Biliary Pancreatitis * Severe or moderately severe post-ERCP pancreatitis * Chronic pancreatitis * Bile duct pathology * Widespread malignancy * Unable to give consent

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Conditions

The condition(s) this trial relates to.

choledocholithiasis cholelithiasis

As listed by the trial registrant

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

Cholecystectomy, laparoscopic Choledocholithiasis Cholelithiasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helsinki University Hospital, Jorvi

    RECRUITING

    Espoo, Finland

  • Helsinki University Hospital, Meilahti

    RECRUITING

    Helsinki, Finland

  • Kanta-Häme Central Hospital

    NOT_YET_RECRUITING

    Hämeenlinna, Finland

  • Keski-Suomi Central Hospital

    NOT_YET_RECRUITING

    Jyväskylä, Finland

  • Kuopio University Hospital

    NOT_YET_RECRUITING

    Kuopio, Finland

  • Kymenlaakso Central Hospital

    NOT_YET_RECRUITING

    Kotka, Finland

  • Oulu University Hospital

    NOT_YET_RECRUITING

    Oulu, Finland

  • Pohjois-Karjala Central Hospital

    NOT_YET_RECRUITING

    Joensuu, Finland

  • Päijät-Häme Central Hospital

    NOT_YET_RECRUITING

    Lahti, Finland

  • Tampere University Hospital

    NOT_YET_RECRUITING

    Tampere, Finland

  • Turku University Hospital

    NOT_YET_RECRUITING

    Turku, Finland

  • Vaasa Central Hospital

    NOT_YET_RECRUITING

    Vaasa, Finland

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