Health TrialsbyHealthPanel

Bile Aspiration vs Drain in Acute Cholecystitis

ConditionCholecystitis, Acute
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute cholecystitis, not warranting acute cholecystectomy

Disqualifiers

Indication for acute cholecystectomy, i.e. history < 5 days and no contraindication to surgery

Liver cirrhosis

Ascites

Emphysematous cholecystitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gallbladder aspiration

    Procedure/Surgery

    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.

  • Cholecystostomy

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CholecystostomyActive comparator 1 intervention
Group B: Gallbladder aspirationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Amount of morphine administrated

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

Time frame
24 hours

Secondary outcomes

1

Pain

Pain intensity rated on a Visual Analogue Scale

Time frame
5 days
2

Nausea

Nausea estimated with a Likert scale

Time frame
5 days
3

Re-intervention

Repeated percutaneous aspiration of adjustment of drain

Time frame
5 days
4

Body temperature

Temperature measured daily

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: