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Cholecystitis, AcuteNCT03012243

Bile Aspiration vs Drain in Acute Cholecystitis

A study testing Gallbladder aspiration and Cholecystostomy in people with Cholecystitis, Acute, run by Karolinska Institutet at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholecystitis, Acute
What is being tested?
Gallbladder aspiration and Cholecystostomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
1 Mar 2026to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute cholecystitis, not warranting acute cholecystectomy

Who cannot join

  • Indication for acute cholecystectomy, i.e. history < 5 days and no contraindication to surgery
  • Liver cirrhosis
  • Ascites
  • Emphysematous cholecystitis
  • Gallbladder perforation
  • Suspected malignant condition
Show all 9Show fewer
  • Portal Hypertension
  • Biliary pancreatitis
  • Common bile duct stones

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Agnieszka Popowicz, MD contact

+46 73 582 62 13

a.e.popowicz@gmail.com

Gabriel Sandblom, Assoc Prof contact

+46 70 415 82 18

gabriel.sandblom@ki.se

Sweden1 site
  • Karolinska University Hospital, Center for Digestive Diseases

    Stockholm, 14186

Other trials in Sweden

About this study

Official title: Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis

In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial.

Read the detailed description

Percutaneous cholecystostomy is a minimally invasive technique for treatment of cholecystitis. The cholecystostomy can be inserted transhepatically or transabdominally. The transhepatic route is preferred due to lower risk for bile leakage. The drainage decompresses the gallbladder and drains the bile. This decompression reduces the inflammatory process in the gallbladder. Percutaneous cholecystostomy is often applied in patients not fit for emergency surgery who are in need of intervention due to deterioration of their clinical status. However, even though cholecystostomy is widely practised, it is not fully evaluated.

Percutaneous cholecystostomy has a high success rate, a low procedure-related mortality but a 30 day mortality of 15%. Furthermore, recurrence rates within one year after a cholecystostomy are reported to range between 4 to 22%.

The time duration of the drainage differ between different studies and range from three to six weeks. Optimal timing for drainage has not been studied. Two weeks seem to be sufficient for a maturation of the tract for the transhepatic route and 3 weeks for the transabdominal route. It has been suggested that a prolonged drainage duration is associated with increased risk for recurrence of inflammation due to local irritation of the gallbladder mucosa by the drain.

Percutaneous cholecystostomy is often considered as a bridge to surgery. However, less than half of patients treated with PC are treated with cholecystectomy. This suggests that this treatment is often chosen in a group not fit for surgery and often turns out to be a definitive treatment.

Percutaneous gallbladder aspiration is a technique used for purposes similar to percutaneous cholecystostomy. This technique is an alternative that may be more convenient than percutaneous cholecystostomy. The aspiration is performed with a small gauge needle under ultrasound guidance without leaving a drain. The aspiration leads to a decompression of the gallbladder, which facilitates recovery. However, it has only been described in a few studies and need more evaluation.

One single aspiration may be sufficient to relief symptoms for the majority of patients, but if two aspirations are performed the success rate increases substantially. One randomized controlled trial has been presented where PC is compared to gallbladder aspiration. In this trial PC was superior to gallbladder aspiration in terms of effectiveness. In this trail, however, only one aspiration was performed. No major complications occurred in either group and minor complications were equal between the groups. In a retrospective study comparing aspiration with PC it was found that gallbladder aspiration is safer than PC and has a comparable clinical outcome.

It is believed that single decompressions are sufficient for reduction of the intraluminal pressure. Only a minority of patients have positive bile cultures which, indicates that infection is not a key mechanism in development of cholecystitis, which indicates that a continuous drainage may not be necessary. As lower rates of complications are reported for aspiration due to usage of smaller needle and no drain left that can dislocate and cause bile leakage which is feared complication of PC. It is suggested that PC can have a role as a salvage method when aspiration is not successful.

In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial.

Being tested
Gallbladder aspiration, Cholecystostomy
Medical subject headings
Cholecystitis, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gallbladder aspirationProcedure or surgery

    Also called Percutaneous intervention

    Percutaneous ultrasound-guided aspiration of bile from the gallbladder. This is performed without leaving a drain in the gallbladder. The aspiration is performed with the intention to relief the pressure in the gallbladder, without drain.

  • CholecystostomyProcedure or surgery

    Also called Percutaneous intervention

    Ultrasound-guided insertion of drain in the gallbladder. The drain is left in the gallbladder until clinical assessment and laboratory analyses show that the acute cholecystitis has been successfully treated.

Study groups in NCT03012243
Study groupRoleWhat they receive
CholecystostomyActive comparatorPercutaneous cholecystostomy, leaving drain in situ
Receives: Procedure: Cholecystostomy
Gallbladder aspirationExperimentalGallblader aspiration without drain
Receives: Procedure: Gallbladder aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of morphine administrated

    The total amount of morphine required to relieve the pain the first 24 hours

    Measured: 24 hours

Secondary outcomes (8)
  1. Pain

    Pain intensity rated on a Visual Analogue Scale

    Measured: 5 days

  2. Nausea

    Nausea estimated with a Likert scale

    Measured: 5 days

  3. Re-intervention

    Repeated percutaneous aspiration of adjustment of drain

    Measured: 5 days

  4. Body temperature

    Temperature measured daily

    Measured: 5 days

  5. CRP

    Daily measures of C-reactive protein

    Measured: 5 days

  6. LPK

    Daily measures of Leukocyte particle Concentration

    Measured: 5 days

  7. Time to discharge

    Time from intervention to discharge from the hospital

    Measured: 30 days

  8. Complications

    Procedure-related complications

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03012243
Sponsor's protocol ID
Bile aspiration vs drain trial
Status last verified
Aug 2025
First submitted
4 Jan 2017
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gallbladder aspiration and Cholecystostomy in people with Cholecystitis, Acute, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Agnieszka Popowicz, MD (+46 73 582 62 13, a.e.popowicz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of morphine administrated (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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