Skip to content

Bile Aspiration vs Drain in Acute Cholecystitis

Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03012243
Enrollment
40
Registered
2017-01-06
Start date
2026-03-01
Completion date
2028-03-31
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Acute

Brief 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.

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.

Interventions

PROCEDUREGallbladder aspiration

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.

PROCEDURECholecystostomy

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of morphine administrated24 hoursThe total amount of morphine required to relieve the pain the first 24 hours

Secondary

MeasureTime frameDescription
Nausea5 daysNausea estimated with a Likert scale
Re-intervention5 daysRepeated percutaneous aspiration of adjustment of drain
Body temperature5 daysTemperature measured daily
Pain5 daysPain intensity rated on a Visual Analogue Scale
LPK5 daysDaily measures of Leukocyte particle Concentration
Time to discharge30 daysTime from intervention to discharge from the hospital
Complications30 daysProcedure-related complications
CRP5 daysDaily measures of C-reactive protein

Countries

Sweden

Contacts

Primary ContactAgnieszka Popowicz, MD
a.e.popowicz@gmail.com+46 73 582 62 13
Backup ContactGabriel Sandblom, Assoc Prof
gabriel.sandblom@ki.se+46 70 415 82 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026