Bile Aspiration vs Drain in Acute Cholecystitis

Cholecystitis, Acute Clinical Trial

Official title:

Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03012243
• Other study ID #: Bile aspiration vs drain trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: Agnieszka Popowicz, MD
• Phone: +46 73 582 62 13
• Email: a.e.popowicz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Gallbladder 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.
• Cholecystostomy
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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Center for Digestive Diseases	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of morphine administrated	The total amount of morphine required to relieve the pain the first 24 hours	24 hours
Secondary	Pain	Pain intensity rated on a Visual Analogue Scale	5 days
Secondary	Nausea	Nausea estimated with a Likert scale	5 days
Secondary	Re-intervention	Repeated percutaneous aspiration of adjustment of drain	5 days
Secondary	Body temperature	Temperature measured daily	5 days
Secondary	CRP	Daily measures of C-reactive protein	5 days
Secondary	LPK	Daily measures of Leukocyte particle Concentration	5 days
Secondary	Time to discharge	Time from intervention to discharge from the hospital	30 days
Secondary	Complications	Procedure-related complications	30 days