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NCT Number: NCT03012243

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital, Center for Digestive Diseases

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute cholecystitis, not warranting acute cholecystectomy

Exclusion criteria

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

Treatment and study plan

Gallbladder aspiration

Procedure

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.

Other names: Percutaneous intervention

Cholecystostomy

Procedure

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.

Other names: Percutaneous intervention

Primary outcomes

  1. Amount of morphine administrated

    Time frame: 24 hours

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

Secondary outcomes

  1. Pain

    Time frame: 5 days

    Pain intensity rated on a Visual Analogue Scale

  2. Nausea

    Time frame: 5 days

    Nausea estimated with a Likert scale

  3. Re-intervention

    Time frame: 5 days

    Repeated percutaneous aspiration of adjustment of drain

  4. Body temperature

    Time frame: 5 days

    Temperature measured daily

  5. CRP

    Time frame: 5 days

    Daily measures of C-reactive protein

  6. LPK

    Time frame: 5 days

    Daily measures of Leukocyte particle Concentration

  7. Time to discharge

    Time frame: 30 days

    Time from intervention to discharge from the hospital

  8. Complications

    Time frame: 30 days

    Procedure-related complications

Study contacts

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

Agnieszka Popowicz, MD

CONTACT

[email protected]

+46 73 582 62 13

Gabriel Sandblom, Assoc Prof

CONTACT

[email protected]

+46 70 415 82 18

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2017
Registry last updated
Aug 13, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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